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A wholesale food establishment that processes acidified foods shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard as follows:
All operators of processing and packaging systems shall be under the operating supervision of a person who has:
attended a school giving instruction in food-handling techniques, food-protection principles, personal hygiene and plant sanitation practices, pH controls and critical factors in acidification; and
been identified by that school as having satisfactorily completed the prescribed course of instruction. A U.S. Food and Drug Administration (FDA) sponsored Better Processing Control School is an approved school. Other equivalent schools approved by the department may be attended. The department shall consider students who have satisfactorily completed required portions of the school to be in compliance with the requirement of this subdivision.
Acidified foods shall be manufactured, processed, and packaged so that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the scheduled process. Acidified foods shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance, such as yeast and mold, capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. FDA approved preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance in lieu of thermal processing.
Sufficient control, including frequent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Measurement of acidity of foods in process may be made by potentiometric methods, titratable acidity, or colorimetric methods. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by titration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suitable method. When food ingredients have been subjected to lye, lime, or similar high pH materials, they may alter the pH of the product.
Procedures for acidification to attain acceptable equilibrium pH levels in the final food include, but are not limited to, the following:
Blanching of the food ingredients in acidified aqueous solutions.
Immersion of the blanched food in acid solutions. Although immersion of food in an acid solution is a satisfactory method for acidification, process controls must be taken to ensure that the acid concentration is properly maintained.
Direct batch acidification, which can be achieved by adding a known amount of an acid solution to a specified amount of food during acidification.
Direct addition of a predetermined amount of acid to individual containers during production. Liquid acids are generally more effective than solid or pelleted acids. Process controls must be taken to ensure that the proper amount of acid is added to each container.
Addition of acid foods to low-acid foods in controlled proportions to conform to specific formulations.
Testing and examinations of containers shall occur often enough to ensure that the container suitably protects the food from leakage or contamination.
pH meters shall be standardized to get an accurate pH measurement. The directions for standardization and storage supplied by the manufacturer of the equipment shall be followed.
Each container or product shall be marked with an identifying code permanently visible to the naked eye. If the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, as long as the label is securely affixed to the product container. The required identification shall specify in code the wholesale food establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed. The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one (1) of the following bases:
Intervals of four (4) to five (5) hours.
Personnel shift changes.
Batches, as long as the containers constituting the batch do not represent those processed during more than one (1) personnel shift.
A qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods shall establish the scheduled process and be considered a processing authority. A written document or published paper prepared by experts in acidified food processing, such as the "Ball Canning Book," may qualify. Any modifications to a process listed in a document or paper shall be substantiated by a qualified person and that person shall be listed as the processing authority. Copies of the scheduled process shall be kept at the facility.
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 do any of the following:
Fully reprocess that portion of the food by a process established by a competent processing authority as effective to ensure a safe product.
Thermally process the food as a low-acid food under 21 CFR 113.
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 microorganisms 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
Records shall be maintained of examinations of raw materials, packaging materials and finished products and of suppliers' guarantees or certifications that verify compliance with this regulation.
Processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, shall be maintained and shall contain sufficient additional information such as product code, date, container size and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production.
Records shall be kept of all departures from scheduled processes having a possible bearing on public health or the safety of the food. The records shall delineate the action taken and the final disposition of the product involved.
Records shall be maintained identifying initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use.
If a processor makes an electronic record of pH by connection of the pH meter to a computer or by manually keying the pH values into a computer as the primary record, then that record is subject to 21 CFR 11.
Copies of all records provided for in subdivisions (10) through (14) shall be retained at the processing plant or other reasonable, accessible location for a period of three (3) years from the date of manufacture.