PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264. Source: 44 FR 16215, Mar. 16, 1979, unless otherwise noted. Subpart A—General Provisions § 113.3 Definitions. For the purposes of this part, the following definitions apply: (a) Aseptic processing and packaging (b) Bleeders (c) Come-up-time (d) Commercial processor (e) Commercial sterility: (i) By the application of heat which renders the food free of— ( a ( b (ii) By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. (2) “Commercial sterility” of equipment and containers used for aseptic processing and packaging of food means the condition achieved by application of heat, chemical sterilant(s), or other appropriate treatment that renders the equipment and containers free of viable microorganisms having public health significance, as well as microorganisms of nonhealth significance, capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. (f) Critical factor (g) Flame sterilizer (h) Headspace, gross (i) Headspace, net (j) Hermetically sealed container (k) Incubation (l) Initial temperature (m) Lot (n) Low-acid foods w (o) Minimum thermal process (p) Operating process (q) Retort (r) Scheduled process (s) Shall (t) Should (u) Vacuum-packed products (v) Vents (w) Water activity w § 113.5 Current good manufacturing practice. The criteria in §§ 113.10, 113.40, 113.60, 113.81, 113.83, 113.87, 113.89, and 113.100 shall apply in determining whether the facilities, methods, practices, and controls used by the commercial processor in the manufacture, processing, or packing of low-acid foods in hermetically sealed containers are operated or administered in a manner adequate to protect the public health. § 113.10 Personnel. The operators of processing systems, retorts, aseptic processing and packaging systems and product formulating systems (including systems wherein water activity is used in conjunction with thermal processing) and container closure inspectors shall be under the operating supervision of a person who has attended a school approved by the Commissioner for giving instruction appropriate to the preservation technology involved and who has been identified by that school as having satisfactorily completed the prescribed course of instruction. This person shall supervise only in those areas for which a school approved by the Commissioner identifies the person as having satisfactorily completed training. Subpart B [Reserved] Subpart C—Equipment § 113.40 Equipment and procedures. (a) Equipment and procedures for pressure processing in steam in still retorts Temperature-indicating device. (i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. (ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced. (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 °F per inch (4 °C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective. (v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a 3/4 1/16 (2) Temperature-recording device. 1/16 (i) Analog or graphical recordings. (ii) Digital recordings. (iii) Adjustments. (iv) Temperature controller. (3) Pressure gages. (4) Steam controller. (5) Steam inlet. (6) Crate supports. (7) Steam spreaders. (8) Bleeders. (9) Stacking equipment and position of containers. etc., (10) Air valves. (11) Water valves. (12) Vents. (i) Venting horizontal retorts. ( 1 Specifications. ( 2 Venting method. (B) Venting through multiple 1-inch (2.5 centimeters) vents discharging through a manifold to atmosphere. ( 1 Specifications. ( 2 Venting method. (C) Venting through water spreaders. ( 1 Size of vent and vent valve. ( 2 Size of water spreader. ( 3 Venting method. (D) Venting through a single 2.5-inch (6.4 centimeters) top vent (for retorts not exceeding 15 feet (4.6 meters) in length). ( 1 Specifications. ( 2 Venting method. (ii) Venting vertical retorts. ( 1 Specifications. ( 2 Venting method. (B) Venting through a single 1-inch (2.5 centimeters) side or top vent. ( 1 Specifications. ( 2 Venting method. (iii) Other procedures. (13) Critical factors. (i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process. (ii) Closing machine vacuum in vacuum-packed products shall be observed and recorded at intervals of sufficient frequency to ensure that the vacuum is as specified in the scheduled process. (iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes. (iv) When the product style results in stratification or layering of the primary product in the containers, the positioning of containers in the retort shall be according to the scheduled process. (b) Equipment and procedures for pressure processing in water in still retorts Temperature-indicating device. (i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. (ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced. (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 °F per inch (4 °C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective. (v) Each temperature-indicating device shall be installed where it can be accurately and easily read. In both horizontal and vertical retorts, the temperature-indicating device sensor shall be inserted directly into the retort shell or in a separate well or sleeve attached to the retort. The temperature-indicating device sensor shall be located so that it is beneath the surface of the water throughout the process and where there is adequate circulation to ensure accurate temperature measurement. On horizontal retorts, the temperature-indicating device sensor should be located in the side at the center of the retort. The temperature-indicating device—not the temperature-recording device—shall be the reference instrument for indicating the processing temperature. (2) Temperature-recording device. (i) Analog or graphical recordings. (ii) Digital recordings. (iii) Adjustments. (iv) Temperature controller. (3) Pressure gages. (ii) Each retort should have an adjustable pressure relief or control valve of a capacity sufficient to prevent an undesired increase in retort pressure when the water valve is wide open and should be installed in the overflow line. (4) Steam controller. (5) Steam introduction. (6) Crate supports. (7) Stacking equipment and position of containers. etc., (8) Drain valve. (9) Air supply and controls. (10) Water level indicator. (11) Water circulation. (12) Cooling water supply. (13) Retort headspace. (14) Vertical and horizontal still retorts. Legend for Vertical and Horizontal Still Retorts A—Water line. B—Steam line. C—Temperature control. D—Overflow line. E 1 E 2 F—Check valves. G—Line from hot water storage. H—Suction line and manifold. I—Circulating pump. J—Petcocks. K—Recirculating line. L—Steam distributor. M—Temperature-controller sensor. N—Temperature-indicating device sensor. O—Water spreader. P—Safety valve. Q—Vent valve for steam processing. R—Pressure gage. S—Inlet air control. T—Pressure control. U—Air line. V—To pressure control instrument. W—To temperature control instrument. X—Wing nuts. Y 1 Y 2 Z—Constant flow orifice valve. Z 1 Z 2 (15) Critical factors. (i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process. (ii) Closing machine vacuum in vacuum-packed products shall be observed and recorded at intervals of sufficient frequency to ensure that the vacuum is as specified in the scheduled process. (iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes. (iv) When the product style results in stratification or layering of the primary product in the containers, the positioning of containers in the retort shall be according to the scheduled process. (c) Equipment and procedures for pressure processing in steam in continuous agitating retorts Temperature-indicating device. (i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. (ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced. (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 °F per inch (4 °C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective. (v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a 3/4 1/16 (2) Temperature-recording device. 1/16 (i) Analog or graphical recordings. (ii) Digital recordings. (iii) Adjustments. (iv) Temperature controller. (3) Pressure gages. (4) Steam controller. (5) Bleeders. 1/8 (6) Venting and condensate removal. (7) Retort speed timing. (8) Emergency stops. (i) Any containers in the retort intake valve or in transfer valves between cooker shells of a continuous retort at the time of breakdown shall either be reprocessed, repacked and reprocessed, or discarded. (ii) Both the time at which the reel stopped and the time the retort was used for a still retort process, if so used, shall be indicated on the temperature-recording device record and entered on the other production records required in this chapter. If the alternative procedure of prompt cooling is followed, the subsequent handling methods used for the containers in the retort at the time of stopping and cooling shall be entered on the production records. (9) Temperature drop. (10) Critical factors. (d) Equipment and procedures for pressure processing in steam in discontinuous agitating retorts Temperature-indicating device. (i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. (ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced. (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 °F per inch (4 °C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective. (v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a 3/4 1/16 (2) Temperature-recording device. 1/16 (i) Analog or graphical recordings. (ii) Digital recordings. (iii) Adjustments. (iv) Temperature controller. (3) Pressure gages. (4) Steam controller. (5) Bleeders. 1/8 (6) Venting and condensate removal. (7) Retort speed timing. (8) Critical factors. (e) Equipment and procedures for pressure processing in water in discontinuous agitating retorts Temperature-indicating device. (i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. (ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced. (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 °F per inch (4 °C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective. (v) Each temperature-indicating device shall be installed where it can be accurately and easily read. In both horizontal and vertical retorts, the temperature-indicating device sensor shall be inserted directly into the retort shell or in a separate well or sleeve attached to the retort. The temperature-indicating device sensor shall be located so that it is beneath the surface of the water throughout the process and where there is adequate circulation to ensure accurate temperature measurement. On horizontal retorts, the temperature-indicating device sensor should be located in the side at the center of the retort. The temperature-indicating device—not the temperature-recording device—shall be the reference instrument for indicating the processing temperature. (2) Temperature-recording device. (i) Analog or graphical recordings. (ii) Digital recordings. (iii) Adjustments. (iv) Temperature controller. (3) Pressure gages. (4) Steam controller. (5) Retort speed timing. (6) Air supply and controls. (i) A means shall be provided for introducing compressed air at the proper pressure and rate. The proper pressure shall be controlled by an automatic pressure control unit. A check valve shall be provided in the air supply line to prevent water from entering the system. (ii) A water level indicator, e.g., sensor, gage, water glass, or petcock(s), shall be used for determining the water level in the retort during operation. Water shall cover the top layer of containers during the entire come-up time and processing periods and should also cover the top layer of containers during the cooling periods. The operator shall check and record the water level at intervals sufficient to ensure its adequacy. (7) Water circulation. (8) Drain valve. (9) Critical factors. (f) Equipment and procedures for pressure processing in steam in hydrostatic retorts Temperature-indicating device. (i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. (ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced. (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 °F per inch (4 °C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective. (v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be located in the steam dome near the steam-water interface. When the scheduled process specifies maintenance of particular temperatures in the hydrostatic water legs, a temperature-indicating device sensor shall be located in each hydrostatic water leg in a position near the bottom temperature-recording device sensor. The temperature-indicating device—not the temperature-recording device—shall be the reference instrument for indicating the processing temperature. (2) Temperature-recording device. 1/16 (i) Analog or graphical recordings. (ii) Digital recordings. (iii) Adjustments. (iv) Temperature controller. (3) Pressure gages. (4) Recording of temperatures. (i) In the steam chamber between the steam-water interface and the lowest container position. (ii) Near the top and the bottom of each hydrostatic water leg if the scheduled process specifies maintenance of particular temperatures in the legs. (5) Steam controller. (6) Venting. (7) Bleeders. 1/4 (8) Retort speed. (9) Critical factors. (i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process. (ii) Closing machine vacuum in vacuum-packed products shall be observed and recorded at intervals of sufficient frequency to ensure that the vacuum is as specified in the scheduled process. (iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes. (g) Aseptic processing and packaging systems Product sterilizer Equipment Temperature-indicating device. ( 1 ( 2 ( 3 ( 4 ( 5 (B) Temperature-recording device. ( 1 Analog or graphical recordings. ( 2 Digital recordings. ( 3 Adjustments. (C) Temperature controller. (D) Product-to-product regenerators. (E) Differential pressure recorder-controller. ( 1 Analog or graphical recordings. ( 2 Digital recordings. (F) Flow control. (G) Product holding tube. 1/4 (H) Flow-diversion systems. (I) Equipment downstream from the holding tube. (ii) Operation Startup. (B) Temperature drop in product-sterilizing holding tube. (C) Loss of proper pressures in the regenerator. (D) Loss of sterile air pressure or other protection level in the aseptic surge tank. (E) Records. (2) Container sterilizing, filling, and closing operation Equipment Recording device. (B) Timing method(s). (ii) Operation Startup. (B) Loss of sterility. (C) Records. (3) Incubation. (4) Critical factors. (h) Equipment and procedures for flame sterilizers. (1) Process interruption. (2) Critical factors. (i) Equipment and procedures for thermal processing of foods wherein critical factors such as water activity are used in conjunction with thermal processing. (j) Other systems. [76 FR 11906, Mar. 3, 2011; 76 FR 81363, Dec. 28, 2011] Subpart D—Control of Components, Food Product Containers, Closures, and In-Process Materials § 113.60 Containers. (a) Closures. (1) Teardown examinations for double-seam cans shall be performed by a qualified individual and the results therefrom shall be recorded at intervals of sufficient frequency on enough containers from each seaming station to ensure maintenance of seam integrity. Such examinations and recordings should be made at intervals not to exceed 4 hours. The results of the teardown examinations shall be recorded and the corrective action taken, if any, shall be noted. (i) Required and optional can seam measurements: ( a Required Optional Cover hook Overlap (by calculation). Body hook Countersink. Width (length, height) Tightness (observation for wrinkle) Thickness ( b Required Optional Body hook Width (length, height). Overlap Cover hook. Tightness (observation for wrinkle) Countersink. Thickness by micrometer ( c ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 (ii) Two measurements at different locations, excluding the side seam, shall be made for each double seam characteristic if a seam scope or seam projector is used. When a micrometer is used, three measurements shall be made at points approximately 120° apart, excluding the side seam. (iii) Overlap length can be calculated by the following formula: The theoretical overlap length = CH + BH + T − W, where CH = cover hook BH = body hook T = cover thickness, and W = seam width (height, length) (2) For glass containers with vacuum closures, capper efficiency must be checked by a measurement of the cold water vacuum. This shall be done before actual filling operations, and the results shall be recorded. (3) For closures other than double seams and glass containers, appropriate detailed inspections and tests shall be conducted by qualified personnel at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production. Records of such tests shall be maintained. (b) Cooling water. (c) Coding. (d) Postprocess handling. i.e., etc. [44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11922, Mar. 3, 2011] Subpart E—Production and Process Controls § 113.81 Product preparation. (a) Before using raw materials and ingredients susceptible to microbiological contamination, the processor shall ensure that those materials and ingredients are suitable for use in processing low-acid food. Compliance with this requirement may be accomplished by receiving the raw materials and ingredients under a supplier's guarantee that they are suitable for use, by examining them for their microbiological condition, or by other acceptable means. (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 w w w § 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. Variations include those that occur due to seasonal or growing fluctuations, variety differences, supplier processes, reprocessing, and mixing a batch of processed product with the same unprocessed product before it is processed. Critical factors, e.g., minimum headspace, consistency, maximum fill-in or drained weight, a w etc., [76 FR 11922, Mar. 3, 2011] § 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 record of these checks should be made. (c) The initial temperature of the contents of the containers to be processed shall be accurately 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. The temperature-indicating device used to determine the initial temperature shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device, by appropriate standard procedures, with sufficient frequency to ensure that initial temperature measurements are accurate. Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (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 temperature-recording device records shall reasonably correspond to the time of day on the 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. [44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11923, Mar. 3, 2011] § 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 low-acid food or container system as disclosed from records by processor check or otherwise, the commercial 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 commercial sterility or after the determination 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 deviations 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 temperature-indicating device and temperature-recording device 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. (2) Agitating retorts. (3) Hydrostatic retorts. (4) Aseptic processing and packaging systems. (5) Flame sterilizers. (6) Food preservation methods wherein critical factors such as water activity are used in conjunction with thermal processing. w (7) Other systems. (b) Temperature-recording device records shall be identified by date, retort number, and other data as necessary, so they can be correlated with the 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 than 1 working day after the actual process, and before shipment or release for distribution, a representative of plant management who is qualified 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 temperature-recording device records, shall be signed or initialed and dated by the reviewer. (c) Records of the accuracy of a temperature-indicating device shall include: (1) A reference to the tag, seal, or other means of identity used by the processor to identify the temperature-indicating device; (2) The name of the manufacturer of the temperature-indicating device; (3) The identity of the reference device, equipment, and procedures used for the accuracy test and to adjust the temperature-indicating device or, if an outside facility is used to conduct the accuracy test for the temperature-indicating device, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a National Institute of Standards and Technology (NIST) or other national metrology institute standard; (4) The identity of the person or facility that performed the accuracy test and adjusted or calibrated the temperature-indicating device; (5) The date and results of each accuracy test, including the amount of calibration adjustment; and (6) The date on or before which the next accuracy test must be performed. (d) Records of the accuracy of a reference device maintained by the processor shall include: (1) A reference to the tag, seal, or other means of identity used by the processor to identify the reference device; (2) The name of the manufacturer of the reference device; (3) The identity of the equipment and reference to procedures used for the accuracy test and to adjust or calibrate the reference device or, if an outside facility is used to conduct the accuracy test for the reference device, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a NIST or other national metrology institute standard; (4) The identity of the person or facility that performed the accuracy test and adjusted or calibrated the reference device; (5) The date and results of each accuracy test, including the amount of calibration adjustment; and (6) The date on or before which the next accuracy test must be performed. (e) 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. The records shall be signed or initialed and dated by the reviewer. (f) 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. (g) 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. (h) Records of this part may be maintained electronically, provided they are in compliance with part 11 of this chapter. [44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11923, Mar. 3, 2011]