21 CFR 114.89: Deviations from scheduled processes
Requires processors of acidified foods, when a process deviates from the schedule or finished pH exceeds 4.6, to reprocess, thermally process as low-acid, or hold for expert evaluation, documenting results, and destroy unsafe product.
Part 114, Acidified Foods · Subpart E, Production and Process Controls
Recent 483s citing 114.89
- Fruit of the Earth, Inc. · Grand Prairie, TexasWhen a process operation deviated from the scheduled process or the equilibrium pH… Dec 22, 2021
- Thermo Pac LLC · Stone Mo'untain, GeorgiaProcess-deviations are not evaluated by a competent processing authority in… Jun 3, 2011
The regulation text
§ 114.89 Deviations from scheduled processes.
Whenever any process operation deviates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the commercial processor of the acidified food shall either: (a) Fully reprocess that portion of the food by a process established by a competent processing authority as adequate to ensure a safe product; (b) thermally process it as a low-acid food under part 113 of this chapter; or (c) set aside that portion of the food involved for further evaluation as to any potential public health significance. The evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Unless the evaluation demonstrates that the food has undergone a process that has rendered it safe, the food set aside shall either be fully reprocessed to render it safe, or be destroyed. A record shall be made of the procedures used in the evaluation and the results. Either upon completion of full reprocessing and the attainment of a safe food, or after the determination that no significant potential for public health hazard exists, that portion of the food involved may be shipped in normal distribution. Otherwise, the portion of the food involved shall be destroyed.
Questions
What does 21 CFR 114.89 require?
Requires processors of acidified foods, when a process deviates from the schedule or finished pH exceeds 4.6, to reprocess, thermally process as low-acid, or hold for expert evaluation, documenting results, and destroy unsafe product.
Which sections are cited alongside 114.89?
In the same 483s, investigators most often also cite 108.25 (Acidified foods), 110.80 (Processes and controls), 111.70 (What specifications must you establish?), 111.75 (What must you do to determine whether specifications are met?).