The Process Authority: Definitions and Responsibilities
By Rick Falkenberg Ph.D.
As a certified process authority, I am often asked what a process authority is and what their responsibilities are. The answers to these questions give us a better understanding of the process authority's essential role in the food processing industry.
Unfortunately, when you look up Part 113.3, "Definitions", you will quickly realize that there is no definition listed for what constitutes a process authority. So what is a process authority and what are its responsibilities? The closest existence to a definition of a process authority by the FDA is contained within the "legalese" of the regulations.
The regulations have established the process authority as a "go between" for the FDA and the processor, with respect to compliance with the regulations and evaluation of any potential hazard to public health risk. As a "go between" for the regulatory agencies and the food processor, the process authority works to reach solutions that are reasonable to both the processor and the regulatory agencies and comply with the intent of those regulations.
According to the USDA regulation 9CFR 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."
Using regulatory definitions and descriptions as a foundation, perhaps looking at the many responsibilities a process authority holds under these regulations will paint a clearer, more realistic picture of a process authority. Process authorities have many responsibilities under the regulations. They must establish processes, evaluate processing deviations and keep adequate records of the work done in these areas. Many times they must assume other responsibilities not so clearly delineated in the regulations.
The process authority must recognize the inadequacies or inexperience of a processor in order to provide him with sufficient information to ensure that the processor understands what factors are operationally critical, how to monitor and control them, and what he must do when process failure occurs. The process authority must thoroughly investigate and completely understand innovations or new developments in equipment, product formulation, methods of processing, or any other area and must identify all critical factors which may adversely affect the product/package safety.
Over the years, FDA officials have stated in various presentations that process authorities are required to have knowledge in a variety of scientific disciplines including microbiology, engineering, mathematics, food technology, chemistry, metallurgy and physics. (continue reading >>)