The MU Food Processing and Safety lab reviews acid, formulated acid and acidified food products. Please note that if acidified foods are not processed properly, they may present a health risk to consumers, particularly with botulinum toxin. Due to a number of incidents involving Clostridium botulinum (an anaerobic spore-forming bacteria which produces a protein resulting in neurotoxicity in affected people) poisonings due to improperly processed foods in these categories, the U.S. Food and Drug Administration (FDA) has put in place a set of regulations that require companies to register as processors and submit their processes to the FDA. Most pathogenic microorganisms, including C. botulinum do not grow in acid or acidified food products with pH below 4.6. Hence it is important to manufacture these food products according to a scheduled process with final pH 4.6 or below. Once the pH of the food products is formulated below 4.6, it is important to deliver enough heat for commercial sterility, properly sealed, labeled, record keeping and have a necessary permit/inspection from the state of Missouri. Missouri State has adopted a section of the Code of State Regulations (CSR) to address acid and acidified foods. If an individual is operating a food business, they are to be inspected by either the Local Public Health Agencies (LPHA) or Missouri Department of Health and Senior Services (DHSS) Manufactured Food Program. If a person is making acid or acidified canned foods, they are to be in contact with the LPHA or MDHSS. An individual cannot make these products without being inspected.

• Acid foods are natural food products with pH 4.6 or below.
• A formulated acid food contains majority (>90%) of acid foods but has a small amount of low-acid ingredients (no more than 10% by weight) added with a finished equilibrium pH at or below 4.6.
• Acidified foods are low-acid foods with added acids (commonly lemon juice or vinegar) to lower pH to below 4.6. These have a water activity greater than 0.85 and have a finished equilibrium pH adjusted to 4.6 or below. Examples include, but are not limited to, salsas, pickles, hot sauces, etc.

A person who is canning an acidified food will need to follow the requirements for acidified foods (19 CSR 20-1.042) in addition to Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (cGMPs). The Missouri State Acidified Food Regulations are based on CFR 114 which requires that the process be reviewed by a processing authority and for staff/personnel to attend a Better Process Control School (BPCS).

At the time of the manufacturing, processing, or packaging of acidified or low-acid canned foods (LACF), a commercial food processor shall register and file information with the FDA including the name of the establishment, the principal place of business, the location of each establishment in which the processing is carried on, the processing method, and a list of foods processed in each establishment. Additionally, processors must complete and file, if required, FDA process registration forms: FDA-2451 (Food Canning Establishment Registration) and FDA-2541e (Food Process Filing for Acidified Method) for each acidified food manufactured in each container size. Required within 10 days of production starting; and requires that you have received the process review/scheduled process. The FDA has outlined special sets of GMPs for acidified (21 CFR 114) and low-acid canned (21 CFR 113) foods.

Note that each county in Missouri has a unique regulation to manufacture and process food products for human consumption. So, please contact the Missouri Department of Health and Senior Services, at the District office in your area to discuss the requirements if you are considering starting a low-acid food, acidified food or fermented food-manufacturing operation. Please contact the MDHSS central office for more information about the additional regulations and requirements for processing these products prior to beginning operation.

A food process authority is someone who has the expert knowledge, training, and technical skills to evaluate and approve a food process and/or recipe. Knowledge can be achieved through education or experience or both. A Process Authority will review the recipe or formulations (ingredients), the food processing conditions, storage and distribution conditions, and issues a process review letter along with a scheduled process specific to the food product.

The process authority acts as a bridge between the food manufacturer and the government ensuring safety of the finished food products by issuing an approved scheduled process or process authority letter. A scheduled process will include the product formulation or recipe, step by step procedure to safely manufacture, packaging, storage, and distribution of food products. A scheduled process or a process authority letter is specific to the recipe and the owner of the food manufacturer.

A scheduled process is a set of recipe-specific food manufacturing procedures reviewed and approved by a Process Authority. The main objective is to achieve food safety and protect consumers from foodborne illness outbreaks. A scheduled process or process authority letters provided by the process authority are confidential and will not be shared with others.