There are three types of recognized process authorities for food production mentioned in U.S. federal regulations. In FDA-regulated products there are basically two types of process authority, and there is also a USDA definition of process authority for meat, poultry, and egg products.

For FDA-regulated products, a process authority is somewhat defined in the low acid canned foods regulation and in the acidified foods regulation. In Title 21 Code of Federal Regulations Part 128B entitled “Thermally-Processed Low-Acid Foods Packaged in Hermetically Sealed Containers” (since re-codified as Part 113) it states that low-acid thermal processes shall be established by “qualified persons” with academic and industrial experience related to thermal processing work. By contrast, in the acidified foods regulations (Part 114.83) it states that scheduled processes for acidified foods shall be established by “a qualified person.” Due to this distinction, it is generally accepted that a low-acid canned foods process authority (for products that fall under 21CFR 113) should be more than one individual, typically an expert or experts supported by a laboratory that can work with Clostridium botulinum. Low-acid canned food process authorities have historically been entities such as industry organizations (National Food Processors Association – now GMA) or food testing laboratories with sufficient means to perform various pertinent analyses of food samples which are in hermetically-sealed, reduced oxygen package formats, and which also have qualified, experienced, and competent personnel who understand thermodynamics of heat processing such foods in retorts or other systems and who understand the microbial hazards associated with such products. For acidified foods, it is generally accepted that an individual with sufficient academic degrees, experience, and ability to evaluate the microbiological safety of products can serve as a process authority.

According to the USDA regulation 9 CFR 318.300, entitled “Definitions”, a processing authority is “the person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions as indicated in this subpart.”

In any case, the process authority acts as a liaison between the production plant and the government to assure safe production of foods and beverages. Process authority status is not an official certification of an individual or group, but rather the unofficial recognition that an individual or group possess the knowledge and experience in areas such as thermobacteriology, process engineering, retort or pasteurization equipment design, performance, and sanitation, etc. In the U.S. the recognition would come rather informally through peer-recognition in the form of processor(s) and government’s willingness to work with the person(s) to qualify a food process. It should be noted that a process authority for USDA regulated meat, poultry, and egg products may not be deemed an authority by FDA authorities responsible for regulating low-acid canned foods, and vice versa, since the areas of expertise necessary differ slightly. That’s why experience in both types of regulated products is important, and that’s what Etna Consulting Group offers. We offer Ph.D. level expertise, industry experience in a wide range of food and beverage products and processes, nationally certified microbiologists, and collaboration with biosafety level 2 and level 3 laboratories that enable us to serve as a process authority for many FDA- and USDA-regulated products.

Whenever a product meets the definition of foods that fall under the FDA regulations for low-acid canned foods (21 CRF 113) or acidified foods (21 CFR 114), a scheduled process must be filed with the FDA using certain online forms:

• FDA 2541 – Food Canning Establishment Registration
• FDA 2541d – Food Process Filing for Low-Acid Retorted Method
• FDA 2541e – Food Process Filing for Acidified Method
• FDA 2541f – Food Process Filing for Water Activity/Formulation Control Method
• FDA 2541g – Food Process Filing for Low-Acid Aseptic Systems

These forms are now available on FDA’s web site. A processor must file the form and state whether a process authority has approved the process. That’s where we come in. Etna Consulting Group can review your information and deliver a Process Authority Letter to accompany FDA 2541e (acidified foods), which helps you get your process schedule accepted by and filed with the FDA and state inspection agencies.

We can certainly do those too. Dr. Peter Taormina of Etna Consulting Group is a recognized process authority for meat and poultry products, having spent 13 years working for the world’s largest pork producer, and having co-chaired the Scientific Advisory Committee for the North American Meat Institute. These types of process authority reviews vary from cooking and cooling deviations to re-processing contaminated product to reviewing and opening on processing data for meat and poultry interventions. We also can review fermentation and drying of meat and poultry products and dehydration of pet food products.

Contact Etna Consulting Group to get started. We will ask you a series of questions to find out more about your product, process, or situation. In most cases, we ask that you provide details about your product formulation, processing conditions, packaging format, and how it is to be distributed, stored, or displayed for sale. We have a standard product/process information form that you can fill out on your own time.

Once we get a better understanding of what it is you need, we may suggest some chemistry tests for samples you provide. Then our expert microbiologists check your product and process for compliance with the regulations. If your product and process appear to be fully compliant with the regulations, we simply state that and our Ph.D. process authority will sign off on it. You then attach the letter to your 2541e and submit to the FDA.

If your product is an acidified food (as defined by 21 CFR 114), or if you cannot demonstrate that it is not an acidified food, then you will have no choice of whether or not to schedule your process, and you will be required by FDA to follow the various quality assurance and good manufacturing practices and record keeping procedures outlined in the document. For example, you would have to follow the production and process controls (such as heat requirement). Sometimes, formulations that result in low pH (acidic) food products won’t necessarily fall under the definition of acidified foods because they are instead actually “acid foods.” If you make an acid food, you are not required to follow the acidified foods regulation.

Acid foods are foods that have a natural pH of 4.6 or below.  Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, “pickles” or “pickled —.” Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low- acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this part.”

The highlighted portion above is known as the “small amount provision.”  If a product is determined to be an acid food containing small amounts of low acid food(s), then it is excluded from the production and process controls (such as heat requirement) listed in 21 CFR subpart E 114.80.  I can tell you that FDA or state inspection agencies will likely assume an ambient-stored sauce/paste/slather product is an “acidified food” unless you can prove otherwise.

The first step is to find out if the finished product is marketed and sold as shelf-stable and whether it has water activity less than or equal to 0.85 AND has pH less than or equal to 4.6.  Such products are excluded from the acidified foods reg.  This can easily be done by sending samples of each product in for chemistry (pH and aw).  For any other ambient-stored products not meeting such criteria more work is required based on the FDA Guidance for Industry.  In order to determine if a product is an acid food containing small amounts of low-acid food it needs to follow two basic criteria:

1. No more than 10% of the formula by weight can be low-acid food(s), and
2. The addition of the predominant acid should not cause a “significant difference in pH.”

Sauces, pastes, dressings, slathers, and similar products often fall on the cusp of this definition. Keep in mind, water is considered a low-acid ingredient by FDA.  Therefore, we recommend that clients perform due diligence and utilize our expertise as a process authority to make these determinations.  For us to assess these products, we need the evaluation form filled out for each product.  If the client prefers, they can simply send samples of ingredients and Etna Consulting Group and we can do the pH.  If pH cannot be determined for every ingredient, we can consult pH tables and see if we can find pH for the ingredients.

Etna Consulting Group has a long history of working with the food industry to deliver technically excellent hazard analysis and consultation on microbial food safety risks. We will not give you a form letter with your product and process specifics filled into the blanks. We carefully assess the details you provide about your production process and formulation. We answer your questions along the way. Our experts are just as credentialed as university professors. We respond rapidly.