(b) Blanching by heat, when required in the preparation of food for canning, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent processing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by cleaning. If the blanched food product is washed before filling, potable water should be used.

(c) The filling of containers, either mechanically or by hand, shall be controlled so as to ensure that the filling requirements specified in the scheduled process are met.

(d) The exhausting of containers for the removal of air shall be controlled so as to meet the conditions for which the process was designed. Compliance with the requirement may be accomplished by heat exhausting, mechanical exhausting, hot brining, or steam injection.

(e) When the maintenance of pH (above 4.6) of a normally low-acid food is a basis for a scheduled process, there shall be careful supervision to ensure that the equilibrium pH of the finished product meets that of the scheduled process. The methodology described in § 114.90 of this chapter should be used.

(f) When the scheduled process sets forth critical factors to prevent the growth of microorganisms not destroyed by the thermal process, the factors shall be carefully controlled to ensure that the limits established in the scheduled process are not exceeded. When normally low-acid foods require sufficient solute to permit safe processing at low temperatures, such as in boiling water, there shall be careful supervision to ensure that the equilibrium water activity (a) of the finished product meets that of the scheduled process. The scheduled thermal processes for foods having an aw greater than 0.85 and less than the aw that would allow the growth of spores of microorganisms of public health significance shall be sufficient to render the food free of microorganisms capable of reproducing in the

food under normal nonrefrigerated conditions of storage and distribution.

§ 113.83 Establishing scheduled processes.

Scheduled processes for low-acid foods shall be established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations. The type, range, and combination of variations encountered in commercial production shall be adequately provided for in establishing the scheduled process. Critical factors, e.g., minimum headspace, consistency, maximum fillin or drained weight, aw, etc., that may affect the scheduled process, shall be specified in the scheduled process. Acceptable scientific methods of establishing heat sterilization processes shall include, when necessary, but shall not be limited to, microbial thermal death time data, process calculations based on product heat penetration data, and inoculated packs. Calculation shall be performed according to procedures recognized by competent processing authorities. If incubation tests are necessary for process confirmation, they shall include containers from test trials and from actual commercial production runs during the period of instituting the process. The incubation tests for confirmation of the scheduled processes should include the containers from the test trials and a number of containers from each of four or more actual commercial production runs. The number of containers from actual commercial production runs should be determined on the basis of recognized scientific methods to be of a size sufficient to ensure the adequacy of the process. Complete records covering all aspects of the establishment of the process and associated incubation tests shall be prepared and shall be permanently retained by the person or organization making the determination.

§ 113.87 Operations in the thermal processing room.

(a) Operating processes and retort venting procedures to be used for each product and container size being

packed shall either be posted in a conspicuous place near the processing equipment or be made readily available to the retort or processing system operator and any duly authorized employee of the Food and Drug Administration. Scheduled processes must be made readily available to the supervisor and any duly authorized employee of the Food and Drug Administration.

(b) A system for product traffic control in the retort room shall be established to prevent unretorted product from bypassing the retort process. Each retort basket, truck, car, or crate used to hold containers in a retort, or one or more containers therein, shall, if it contains any retorted food product, be plainly and conspicuously marked with a heat-sensitive indicator, or by other effective means that will indicate visually, to thermal processing personnel, those units that have been retorted. A visual check shall be performed to determine whether or not the appropriate change has occurred in the heat-sensitive indicator as a result of retorting for all retort baskets, trucks, cars, or crates, to ensure that each unit of product has been retorted. A written record of these checks should be made.

(c) The initial temperature of the contents of the containers to be processed shall be determined and recorded with sufficient frequency to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process. For those operations that use water during the filling of the retort or during processing, provision shall be made to ensure that the water will not, before the start of each thermal process, lower the initial temperature of the product below that specified in the scheduled process.

(d) Timing devices used in recording thermal process time information shall be accurate to the extent needed to ensure that the processing time and venting time specified in the scheduled process are achieved. Pocket or wrist watches are not considered satisfactory for timing purposes. Digital clocks may be used if the operating process and the venting schedule have a 1-minute or greater safety factor over the scheduled process.

(e) Clock times on recording-temperature charts should reasonably correspond to the time of day on the written processing records to provide correlation of these records.

(f) The steam supply to the thermal processing system shall be adequate to the extent needed to ensure that sufficient steam pressure is maintained during thermal processing, regardless of other demands of steam by the plant.

(g) If mufflers are used on bleeders or vent systems, evidence that the bleeders or vents are operated in a manner that does not significantly impede the removal of air shall be kept on file. This evidence may be in the form of heat distribution data or other satisfactory evidence such as a letter from the manufacturer, the designer, or a competent processing authority.

§ 113.89 Deviations in processing, venting, or control of critical factors.

Whenever any process is less than the scheduled process or when critical factors are out of control for any lowacid food or container system as disclosed from records by processor check or otherwise, the commerical processor of that low-acid food shall either fully reprocess that portion of the production involved, keeping full records of the reprocessing conditions or, alternatively, must set aside that portion of the product involved for further evaluation as to any potential public health significance. Such 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 this evaluation demonstrates that the product had been given a thermal process that rendered it free of microorganisms of potential public health significance, the product set aside shall be either fully reprocessed to render it commercially sterile or destroyed. A record shall be made of the evaluation procedures used and the results. Either upon completion of full reprocessing and the attainment of commerical sterility or after the deter

mination that no significant potential for public health hazard exists, that portion of the product involved may be shipped in normal distribution. Otherwise, the portion of the product involved shall be destroyed. All process deviations involving a failure to satisfy the minimum requirements of the scheduled process, including emergencies arising from a jam or breakdown of a continuous agitating retort necessitating cooling the retort for repairs, shall be recorded and made the subject of a separate file (or a log identifying the appropriate data) detailing those diviations and the actions taken.

Subpart F-Records and Reports

§ 113.100 Processing and production records.

(a) Processing and production information shall be entered at the time it is observed by the retort or processing system operator, or other designated person, on forms that include the product, the code number, the date, the retort or processing system number, the size of container, the approximate number of containers per coding interval, the initial temperature, the actual processing time, the mercury-in-glass and recording thermometer readings, and other appropriate processing data. Closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, or other critical factors specified in the scheduled process shall also be recorded. In addition, the following records shall be maintained:

(1) Still retorts. Time steam on; time temperature up to processing temperature; time steam off; venting time and temperature to which vented.

(2) Agitating retorts. Functioning of condensate bleeder; retort speed; and, when specified in the scheduled process, headspace, consistency, maximum drained weight, minimum net weight, and percent solids.

(3) Hydrostatic retorts. The temperature in the steam chamber between the steam-water interface and the lowest container position; speed of the container conveyor chain; and, when the scheduled process specifies

maintenance of particular temperatures in the hydrostatic water legs, the temperatures near the top and the bottom of each hydrostatic water leg. (4) Aseptic processing and packaging systems. Product temperature in the holding tube outlet as indicated by the temperature-indicating device and the temperature recorder; product temperature in the final heater outlet as indicated by the temperature recordercontroller; differential pressure as indicated by the differential pressure recorder-controller, if a product-to-product regenerator is used; product flow rate, as determined by the metering pump or by filling and closing rates; sterilization media flow rate or temperature or both; retention time of containers, and closures when applicable, in the sterilizing environment; and, when a batch system is used for container and/or closure sterilization, sterilization cycle times and temperatures.

(5) Flame sterilizers. Container conveyor speed; surface temperature at the beginning and at the end of the holding period; nature of container.

(6) Food preservation methods wherein critical factors such as water activity are used in conjunction with thermal processing. Product formulation and scheduled processes used, including the thermal process, its associated critical factors, as well as other critical factors, and results of a determinations.

(7) Other systems. Critical factors specified in the formulation of the product or in the scheduled process.

(b) Recording thermometer charts shall be identified by date, retort number, and other data as necessary, so they can be correlated with the written record of lots processed. Each entry on the processing and production records shall be made by the retort or processing system operator, or other designated person, at the time the specific retort or processing system condition or operation occurs, and this retort or processing system operator or other designated person shall sign or initial each record form. Not later that 1 working day after the actual process, and before shipment or release for distribution, a representative of plant management who is quali

fied by suitable training or experience shall review all processing and production records for completeness and to ensure that the product received the scheduled process. The records, including the recording thermometer chart(s), shall be signed or initialed and dated by the reviewer.

(c) Written records of all container closure examinations shall specify the product code, the date and time of container closure inspections, the measurements obtained, and all corrective actions taken. Records shall be signed or initialed by the container closure inspector and reviewed by management with sufficient frequency to ensure that the containers are hermetically sealed.

(d) Records shall be maintained to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use.

(e) Copies of all records provided for in this part, except those required under § 113.83 establishing scheduled processes, shall be retained at the processing plant for a period of not less than 1 year from the date of manufacture, and at the processing plant or other reasonably accessible location for an additional 2 years. If, during the first year of the 3-year record-retention period, the processing plant is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack.

"

(b) "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 (a) 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 fo this part. (c) "Lot" means the product produced during a period indicated by a specific code.

(d) "Low-acid foods" means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods.

(e) "Scheduled process" means the process selected by a processor as adequate for use under the conditions of

manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority.

(f) "Shall" is used to state mandatory requirements.

(g) "Should" is used to state recommended or advisory procedures or to identify recommended equipment.

(h) "Water activity" (a) is a measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

§ 114.5 Current good manufacturing practice.

The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in Part 110 of this chapter, apply in determining whether an article of acidified food is adulterated (1) within the meaning of section 402(a)(3) of the act (21 U.S.C. 342(a)(3)) in that it has been manufactured under such conditions that it is unfit for food, or (2) within the meaning of section 402(a)(4) of the act (21 U.S.C. 342(a)(4)) in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

All operators of processing and packaging systems shall be under the operating supervisions of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food-protection principles, personal hygiene and plant sanitation practices, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction. The Commissioner will consider students who have satisfactorily completed the required portions of the courses presented under § 108.35 and Part 113 of this chapter before March

16, 1979, to be in compliance with the requirement of this section.

Subparts B-D-[Reserved]

Subpart E-Production and Process Controls

§ 114.80

Processes and controls.

(a) Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard.

(1) Acidified foods shall be so manufactured, processed, and packaged 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 capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Permitted preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance (in lieu of thermal processing).

(2) 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. Special care should be taken when food ingredients have been subjected to lye, lime, or similar high pH materials.