Sec. 10.15.01.07. Manufacturing Practices for Low-Acid Food and Acidified Food Canning

The person-in-charge shall ensure that:

A. Low-acid foods are processed and labeled in accordance with 21 CFR 113;

B. Acidified foods are processed and labeled in accordance with 21 CFR 114;

C. When canning is taking place, a scheduled process is used that takes into account the critical factors and limits that are likely to influence the food’s safety, stability, or shelf life, such as:

(1) Food characteristics;

(2) Spoilage organisms;

(3) Time and temperature of thermal process;

(4) Cooling parameters;

(5) Acidification;

(6) Storage conditions;

(7) Design and performance of the processing equipment; and

(8) Batch size and configuration;

D. Before a food processing plant processes food in a closed vessel, such as a retort or steam cabinet, a process authority performs a thermal process validation study that includes:

(1) Heat penetration tests;

(2) Heat distribution tests;

(3) Cooling parameters; and

(4) Any other measurements, observations, or calculations needed to ensure that the process is effective and reliable;

E. The scheduled thermal process and validation study are re-established each time there is a change in the processing system; and

F. All thermal processes and validation studies being used are available for inspection by the Department.