MSU Extension Product Center

Clostridium botulinum (C. Botulinum) is a spore forming bacteria capable of producing botulin toxin. Foodborne botulism is caused by eating food contaminated with this toxin. Preventing C. Botulinum in a food product that is stored in a sealed container with little or no oxygen and at room temperature is a legal obligation when you decide to product a food product for commercial sales. 

A Process Authority Review (PAR) is the protocol used to ensure food safety and determine a product’s shelf stability potential. The recipe ingredients, the procedure to make the product, the water content, the packaging, and the product’s storage are all part of the PAR. The need for this protocol is based on the Food and Drug Administration’s (FDA) guidelines in the Code of Federal Regulations (CFR), primarily 21CFR Part 114 (acidified) and 113 (low acid). 

To work with the MSU Product Center for a Process Authority Review, you must first become a client. To register as a client, visit the MSU Product Center’s home page and click on the “Become a Client” button at the top. 

The time range for a Process Authority Review can vary. Most products will need at least 2-3 months to complete this process. Properly made samples and complete PAR forms will help prevent delays. 

The fees associated with PAR services can be categorized into two types of invoices, product testing and letter writing. The general format of a MSU Product Center invoice for PAR product testing services is as follows:

The PAR Review Assistance Fee is $125.00 per project and includes a maximum of two recipes with no more than three ingredient variations between recipes. When a project has more than two recipes or there are more than three ingredient variations between recipes, a fee for Additional PAR Review Recipes is added to the invoice.

The Process Authority will use the product testing results to determine the product classification and subsequent type of letter for your recipe(s). The letter writing invoice from the Process Authority will depend on the classification and time involved (approximately $70.00 - $140.00+).

Your MSU Product Center counselor will provide you with a form to complete to begin the PAR process. This form will require:

1. Recipe Standardization: The recipe that is submitted for the PAR process must be used exactly for commercial production batches. If you don’t have a production ready recipe, do not begin the PAR process. The PAR form will require all ingredients listed in weights (grams, ounces, or pounds) and the brand names of all ingredients. You will also be required to include step-by-step instruction for how the product is made and packaged including cooking times and temperatures. For more information about a commercial ready recipe, see this article.
2. Product Testing: The recipe will be reviewed to determine the type of product testing needed. Food testing could include a pH test to measure the acidity level and/or the water activity (Aw) level. Samples will be required for testing purposes. Do not make samples in advance. Specific instructions for making samples will be sent at the appropriate time.
3. PAR Classification: After products are tested, the Process Authority classifies the product and informs the processor as to whether their recipe and process produces a safe, shelf stable product. Based on this, processors can determine whether they will adjust the recipe and process to meet a different classification or whether they will choose to store the product in refrigeration. The classification letter from the Process Authority is required to secure a food license or as documentation for Health Department or Michigan Department of Agriculture and Rural Development (MDARD) inspection. 

Product Classification

There are four types of product classifications by a Process Authority: 

1. FDA Exempt: A food product with a high percentage of sugar, acid ingredients or a low amount of water, requires a water activity (Aw) test. This is usually the case for jams, hot pepper jellies, and fudge sauces. If you can stand a spoon in the product and it doesn’t fall, an Aw test is appropriate. The goal for these products is to reach FDA Exempt status so there is no need to follow the acidified or acid processing protocols.
2. Acid: Products with contain only acid ingredients (e.g., most fruits) may not needs a pH test to confirm they are an acid. A product with less than 100% acid ingredients (either naturally or manufactured) will require two samples to be tested to ensure safe acid levels. Typical acid food products include barbecue sauces, spaghetti sauces, hot sauces and some salsas. 
3. Acidified: Typical, these products have a large percentage of low-acid ingredients (vegetables, meat, dairy, etc.) with the addition of an acid such as lemon/lime juice or vinegar, which requires a pH test. This product classification category requires FDA registration and an FDA process schedule from a Process Authority. Better Process Control School certification is also required before a license can be secured to manufacture and sell this product. Examples of acidified foods include pickled food products, salsas, and hot sauces made with fresh ingredients. 
4. Low Acid: This category is a food product which contains primarily low acid foods (vegetables, meat, dairy, etc.) and lacks enough acidifying ingredients to keep the pH lower than 4.6. These products will require a commercial pressure realtor for processing, accompanied by significant consulting support from a Process Authority. An FDA process schedule is required, along with a Better Process Control School certificate.

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