PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS Authority: 7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472, 601-695; 7 CFR 2.18, 2.53. Source: 83 FR 25308, May 31, 2018, unless otherwise noted. § 431.1 Definitions. Abnormal container. Acidified low acid product. Bleeders. Canned product. Closure technician. Code lot. Come-up time. Critical factor. Headspace. (1) Gross headspace. i.e., (2) Net headspace. Hermetically sealed containers. (1) Rigid container. 2 i.e., (2) Semirigid container. 2 i.e., (3) Flexible container. Incubation tests. Initial temperature. Low acid product. Process schedule. Process temperature. Process time. Processing authority. Program employee. Retort. Seals. Shelf stability. Thermal process. (1) Time(s) and temperature(s); or (2) Minimum product temperature. Venting. Water activity. § 431.2 Containers and closures. (a) Examination and handling of empty containers. (2) All empty containers, closures, and flexible pouch roll stock must be stored, handled, and conveyed in such a manner that will prevent damage that could affect the hermetic condition of the sealed container. (3) Just before filling, rigid containers must be cleaned to prevent incorporation of foreign matter into the finished product. Closures, semirigid containers, preformed flexible pouches, and flexible pouch roll stock contained in original wrappings do not need to be cleaned before use. (b) Closure examinations for rigid containers (cans) Visual examinations. e.g., (2) Teardown examinations. (i) Dimensional measurement. (A) Micrometer measurement. 1 ( i ( ii ( iii ( iv ( 2 (B) Seamscope or seam projector. (ii) Seam thickness. (iii) Seam tightness. (iv) Side seam juncture rating. (v) Examination of noncylindrical containers. e.g., (c) Closure examinations for glass containers Visual examinations. (2) Closure examinations and tests. (d) Closure examinations for semi-rigid and flexible containers Heat seals Visual examinations. (ii) Physical tests. (2) Recording. (e) Container coding. (f) Handling of containers after closure. (2) The maximum time lapse between closure of containers and initiation of thermal processing must be 2 hours unless data are available from the establishment's processing authority demonstrating that an alternative time period is safe and will not result in product spoilage. § 431.3 Thermal processing. (a) Process schedules. (b) Source of process schedules. (2) Any change in product formulation, ingredients, or treatments that are not already incorporated in a process schedule and that may adversely affect either the product heat penetration profile or sterilization value requirements must be evaluated by the establishment's processing authority. If it is determined that any such change adversely affects the adequacy of the process schedule, the processing authority must amend the process schedule accordingly. (3) Complete records concerning all aspects of the development or determination of a process schedule, including any associated incubation tests, must be made available by the establishment to the Program employee upon request. (c) Submittal of process information. (2) Letters or other written communications from a processing authority recommending all process schedules must be maintained on file by the establishment. Upon request by Program employees, the establishment must make available such letters or written communications (or copies thereof). If critical factors are identified in the process schedule, the establishment must provide the inspector with a copy of the procedures for measuring, controlling, and recording these factors, along with the frequency of such measurements, to ensure that the critical factors remain within the limits used to establish the process schedule. Once submitted, the process schedules and associated critical factors and the procedures for measuring (including the frequency), controlling, and recording of critical factors must not be changed without the prior written submittal of the revised procedures (including supporting documentation) to the inspector at the establishment. § 431.4 Critical factors and the application of the process schedule. Critical factors specified in the process schedule must be measured, controlled, and recorded by the establishment to ensure that these factors remain within the limits used to establish the process schedule. Examples of factors that are often critical to process schedule adequacy may include: (a) General. (2) Arrangement of pieces in the container; (3) Container orientation during thermal processing; (4) Product formulation; (5) Particle size; (6) Maximum thickness for flexible containers, and to some extent semirigid containers, during thermal processing; (7) Maximum pH; (8) Percent salt; (9) Ingoing (or formulated) nitrite level (ppm); (10) Maximum water activity; and (11) Product consistency or viscosity. (b) Continuous rotary and batch agitating retorts. (2) Retort reel speed. (c) Hydrostatic retorts. (2) [Reserved] (d) Steam/air retorts. (2) Heating medium flow rate. § 431.5 Operations in the thermal processing area. (a) Posting of processes. (b) Process indicators and retort traffic control. (c) Initial temperature. (d) Timing devices. (e) Measurement of pH. § 431.6 Equipment and procedures for heat processing systems. (a) Instruments and controls common to different thermal processing systems Indicating temperature devices. (i) Mercury-in-glass thermometers. (ii) Other devices. (2) Temperature/time recording devices. (i) Chart-type devices. (ii) Other devices. (3) Steam controllers. (4) Air valves. (5) Water valves. (b) Pressure processing in steam Common to batch still, batch agitating, continuous rotary retorts, and hydrostats Basic requirements. 3/4 1/16 (ii) Steam inlet. (iii) Bleeder and vent mufflers. (iv) Bleeders. 1/8 1/4 (2) Batch still retorts Crate supports. (ii) Steam spreader. (iii) Condensate removal. (iv) Stacking equipment Equipment for holding or stacking containers in retorts. (B) Divider plates. (v) Vents. (B) Vents must not be connected to a closed drain system without an atmospheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold must be controlled by a gate, plug cock, or other full-flow valve and the manifold must be of a size such that the cross-sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge must not be connected to a closed drain without an atmospheric break in the line. A manifold header connecting vents or manifolds from several still retorts must lead to the atmosphere. The manifold header must not be controlled by a valve and must be of a size such that the cross-sectional area is at least equal to the total cross-sectional area of all connecting retort manifold pipes from the maximum number of retorts to be vented simultaneously. (C) Some typical installations and operating procedures are described below. Other retort installations, vent piping arrangements, operating procedures or auxiliary equipment such as divider plates may be used provided there is documentation that the air is removed from the retort before the process is started. Such documentation must be in the form of heat distribution data or other documentation from the equipment manufacturer or processing authority. This information must be maintained on file by the establishment and made available to Program employees for review. (D) For crateless retort installations, the establishment must have heat distribution data or other documentation from the equipment manufacturer or from a processing authority that demonstrates that the venting procedure used accomplishes the removal of air and condensate. This information must be maintained on file by the establishment and made available to Program employees for review. (E) Examples of typical installations and operating procedures that comply with the requirements of this section are as follows: ( 1 Venting horizontal retorts. i ( ii ( iii ( iv 1/2 ( 2 Venting vertical retorts. i 1/2 ( ii (3) Batch agitating retorts Venting and condensate removal. (ii) Retort or reel speed timing. (4) Continuous rotary retorts Venting and condensate removal. (ii) Retort speed timing. (5) Hydrostatic retorts Basic requirements. 1/16 (ii) Steam inlet. (iii) Bleeders. 1/4 (iv) Venting. (v) Conveyor speed. (vi) Bleeders and vent mufflers. (c) Pressure processing in water Common to batch still and agitating retorts Basic requirements. (ii) Pressure recording device. (iii) Heat distribution. (iv) Drain valve. (2) Batch still retorts Temperature device bulbs and probes. (ii) Crate supports. (iii) Stacking equipment. (iv) Water level. i.e., (v) Air supply and controls. (vi) Water recirculation. (vii) Cooling water entry. (3) Batch agitating retorts Temperature device bulbs and probes. (ii) Stacking equipment. e.g., (iii) Water level. i.e., (iv) Air supply and controls. (v) Retort or reel speed timing. (vi) Water recirculation. (vii) Cooling water entry. (d) Pressure processing with steam/air mixtures in batch retorts Basic requirements. (2) Recording pressure controller. (3) Circulation of steam/air mixtures. (e) Atmospheric cookers Temperature/time recording device. e.g., (2) Heat distribution. (f) Other systems. (g) Equipment maintenance. (2) At least once a year each thermal processing system must be examined by an individual not directly involved in daily operations to ensure the proper functioning of the system as well as all auxiliary equipment and instrumentation. In addition, each thermal processing system should be examined before the resumption of operation following an extended shutdown. (3) Air and water valves that are intended to be closed during thermal processing must be checked by the establishment for leaks. Defective valves must be repaired or replaced as needed. (4) Vent and bleeder mufflers must be checked and maintained or replaced by the establishment to prevent any reduction in bleeder efficiency. (5) When water spreaders are used for venting, a maintenance schedule must be developed and implemented to assure that the holes are maintained at their original size. (6) Records must be kept on all maintenance items that could affect the adequacy of the thermal process. Records must include the date and type of maintenance performed and the person conducting the maintenance. (h) Container cooling and cooling water. (2) Cooling canal water must be chlorinated or treated with a chemical having a bactericidal effect equivalent to chlorination. There must be a measurable residual of the sanitizer in the water at the discharge point of the canal. Cooling canals must be cleaned and replenished with potable water to prevent the buildup of organic matter and other materials. (3) Container cooling waters that are recycled or reused must be handled in systems that are so designed, operated, and maintained so there is no buildup of microorganisms, organic matter, and other materials in the systems and in the waters. System equipment, such as pipelines, holding tanks and cooling towers, must be constructed and installed so that they can be cleaned and inspected. In addition, the establishment must maintain, and make available to Program employees for review, information on at least the following: (i) System design and construction; (ii) System operation including the rates of renewal with fresh, potable water and the means for treating the water so that there is a measurable residual of an acceptable sanitizer, per paragraph (h)(2) of this section, in the water at the point where the water exits the container cooling vessel; (iii) System maintenance including procedures for the periodic cleaning and sanitizing of the entire system; and (iv) Water quality standards, such as microbiological, chemical and physical, monitoring procedures including the frequency and site(s) of sampling, and the corrective actions taken when water quality standards are not met. (i) Post-process handling of containers. § 431.7 Processing and production records. At least the following processing and production information must be recorded by the establishment: Date of production; product name and style; container code; container size and type; and the process schedule, including the minimum initial temperature. Measurements made to satisfy the requirements of § 431.4 regarding the control of critical factors must be recorded. In addition, where applicable, the following information and data must also be recorded: (a) Processing in steam Batch still retorts. (2) Batch agitating retorts. (3) Continuous rotary retorts. (4) Hydrostatic retorts. (b) Processing in water Batch still retorts. (2) Batch agitating retorts. (c) Processing in steam/air mixtures. (d) Atmospheric cookers Batch-type systems. (2) Continuous-type systems. § 431.8 Record review and maintenance. (a) Process records. (b) Automated process monitoring and recordkeeping. (c) Container closure records. (d) Distribution of product. (e) Retention of records. § 431.9 Deviations in processing. (a) Whenever the actual process is less than the process schedule or when any critical factor does not comply with the requirements for that factor as specified in the process schedule, it must be considered a deviation in processing. (b) Deviations in processing (or process deviations) must be handled according to: (1) A HACCP plan for canned product that addresses hazards associated with microbial contamination; or, (2) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or (3) Paragraph (c) of this section. (c) Procedures for handling process deviations where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations. (1) Deviations identified in-process. (i) Immediately reprocess the product using the full process schedule; or (ii) Use an appropriate alternate process schedule provided such a process schedule has been established in accordance with § 431.3(a) and (b) and is filed with the inspector in accordance with § 431.3(c); or (iii) Hold the product involved and have the deviation evaluated by a processing authority to assess the safety and stability of the product. Upon completion of the evaluation, the establishment must provide the inspector the following: (A) A complete description of the deviation along with all necessary supporting documentation; (B) A copy of the evaluation report; and (C) A description of any product disposition actions, either taken or proposed. (iv) Product handled in accordance with paragraph (c)(1)(iii) of this section must not be shipped from the establishment until the Program has reviewed all of the information submitted and approved the product disposition actions. (v) If an alternate process schedule is used that is not on file with the inspector or if an alternate process schedule is immediately calculated and used, the product must be set aside for further evaluation in accordance with paragraphs (c)(1)(iii) and (iv) of this section. (vi) When a deviation occurs in a continuous rotary retort, the product must be handled in accordance with paragraphs (c)(1)(iii) and (iv) of this section or in accordance with the following procedures: (A) Emergency stops. 1 ( 2 (B) Temperature drops. ( 1 ( i ( ii ( iii ( 2 (2) Deviations identified through record review. (d) Process deviation file. § 431.10 Finished product inspection. (a) Finished product inspections must be handled according to: (1) An HACCP plan for canned product that addresses hazards associated with microbiological contamination; (2) An FSIS-approved total quality control system; (3) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or (4) Paragraph (b) of this section. (b) Procedures for handling finished product inspections where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations. (1) Incubation of shelf stable canned produc Incubator. (ii) Incubation temperature. (iii) Product requiring incubation. (A) Low acid products as defined in § 431.1; and (B) Acidified low acid products as defined in § 431.1. (iv) Incubation samples. (B) For continuous rotary retorts, hydrostatic retorts, or other continuous-type thermal processing systems, the establishment must select at least one container per 1,000 for incubation. (C) Only normal-appearing containers must be selected for incubation. (v) Incubation time. (vi) Incubation checks and record maintenance. (vii) Abnormal containers. (viii) Shipping. (2) [Reserved] (c) Container condition Normal containers. (2) Abnormal containers. § 431.11 Personnel and training. All operators of thermal processing systems specified in § 431.6 and container closure technicians must be under the direct supervision of a person who has successfully completed a school of instruction that is generally recognized as adequate for properly training supervisors of canning operations. § 431.12 Recall procedure. Establishments must prepare and maintain a current procedure for the recall of all canned product covered by this subpart. Upon request, the recall procedure must be made available to Program employees for review.