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Electronic Code of Federal Regulations

e-CFR Data is current as of October 29, 2014

Title 9Chapter IIISubchapter APart 381 → Subpart X


Title 9: Animals and Animal Products
PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS


Subpart X—Canning and Canned Products


Contents
§381.300   Definitions.
§381.301   Containers and closures.
§381.302   Thermal processing.
§381.303   Critical factors and the application of the process schedule.
§381.304   Operations in the thermal processing area.
§381.305   Equipment and procedures for heat processing systems.
§381.306   Processing and production records.
§381.307   Record review and maintenance.
§381.308   Deviations in processing.
§381.309   Finished product inspection.
§381.310   Personnel and training.
§381.311   Recall procedure.

Source: 51 FR 45634, Dec. 19, 1986, unless otherwise noted.

§381.300   Definitions.

(a) Abnormal container. A container with any sign of swelling or product leakage or any evidence that the contents of the unopened container may be spoiled.

(b) Acidified low acid product. A canned product which has been formulated or treated so that every component of the finished product has a pH of 4.6 or lower within 24 hours after the completion of the thermal process unless data are available from the establishment's processing authority demonstrating that a longer time period is safe.

(c) Bleeders. Small orifices on a retort through which steam, other gasses, and condensate are emitted from the retort throughout the entire thermal process.

(d) Canned product. A poultry food product with a water activity above 0.85 which receives a thermal process either before or after being packed in a hermetically sealed container. Unless otherwise specified, the term “product” as used in this subpart G shall mean “canned product.”

(e) Closure technician. The individual(s) identified by the establishment as being trained to perform specific container integrity examinations as required by this subpart and designated by the establishment to perform such examinations.

(f) Code lot. All production of a particular product in a specific size container marked with a specific container code.

(g) Come-up time. The elapsed time, including venting time (if applicable), between the introduction of the heating medium into a closed retort and the start of process timing.

(h) Critical factor. Any characteristic, condition or aspect of a product, container, or procedure that affects the adequacy of the process schedule. Critical factors are established by processing authorities.

(i) Headspace. That portion of a container not occupied by the product.

(1) Gross headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the top edge of the container (i.e., the flange of an unsealed can, the top of the double seam on a sealed can, or the top edge of an unsealed jar).

(2) Net headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the inside surface of the lid.

(j) Hermetically sealed containers. Air-tight containers which are designed and intended to protect the contents against the entry of microorganisms during and after thermal processing.

(1) Rigid container. A container, the shape or contour of which, when filled and sealed, is neither affected by the enclosed product nor deformed by external mechanical pressure of up to 10 pounds per square inch gauge (0.7 kg/cm2) (i.e., normal firm finger pressure).

(2) Semirigid container. A container, the shape or contour of which, when filled and sealed, is not significantly affected by the enclosed product under normal atmospheric temperature and pressure, but can be deformed by external mechanical pressure of less than 10 pounds per square inch gauge (0.7 kg/cm2) (i.e., normal firm finger pressure).

(3) Flexible container. A container, the shape or contour of which, when filled and sealed, is significantly affected by the enclosed product.

(k) Incubation tests. Tests in which the thermally processed product is kept at a specific temperature for a specified period of time in order to determine if outgrowth of microorganisms occurs.

(l) Initial temperature. The temperature, determined at the initiation of a thermal process cycle, of the contents of the coldest container to be processed.

(m) Low acid product. A canned product in which any component has a pH value above 4.6.

(n) Process schedule. The thermal process and any specified critical factors for a given canned product required to achieve shelf stability.

(o) Process temperature. The minimum temperature(s) of the heating medium to be maintained as specified in the process schedule.

(p) Process time. The intended time(s) a container is to be exposed to the heating medium while the heating medium is at or above the process temperature(s).

(q) Processing authority. The person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions as indicated in this subpart.

(r) Program employee. Any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program (see §301.2(f)).

(s) Retort. A pressure vessel designed for thermal processing of product packed in hermetically sealed containers.

(t) Seals. Those parts of a semirigid container and lid or of a flexible container that are fused together in order to hermetically close the container.

(u) Shelf stability. The condition achieved by application of heat, sufficient, alone or in combination with other ingredients and/or treatments, to render the product free of microorganisms capable of growing in the product at nonrefrigerated conditions (over 50 °F or 10 °C) at which the product is intended to be held during distribution and storage. Shelf stability and shelf stable are synonymous with commercial sterility and commercially sterile, respectively.

(v) Thermal process. The heat treatment necessary to achieve shelf stability as determined by the establishment's processing authority. It is quantified in terms of:

(1) Time(s) and temperature(s); or

(2) Minimum product temperature.

(w) Venting. The removal of air from a retort before the start of process timing.

(x) Water activity. The ratio of the water vapor pressure of the product to the vapor pressure of pure water at the same temperature.

§381.301   Containers and closures.

(a) Examination and cleaning of empty containers. (1) Empty containers, closures, and flexible pouch roll stock shall be evaluated by the establishment to ensure that they are clean and free of structural defects and damage that may affect product or container integrity. Such an examination should be based upon a statistical sampling plan.

(2) All empty containers, closures, and flexible pouch roll stock shall be stored, handled, and conveyed in such a manner that will prevent soiling and damage that could affect the hermetic condition of the sealed container.

(3) Just before filling, rigid containers shall 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). (1) Visual examinations. A closure technician shall visually examine the double seams formed by each closing machine head. When seam defects (e.g., cutovers, sharpness, knocked down flanges, false seams, droops) are observed, necessary corrective actions, such as adjusting or repairing the closing machine, shall be taken. In addition to the double seams, the entire container shall be examined for product leakage or obvious defects. A visual examination shall be performed on at least one container from each closing machine head, and the observations, along with any corrective actions, shall be recorded. Visual examinations shall be recorded. Visual examinations shall be conducted with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations shall be made by the closure technician at the beginning of production, immediately following every jam in the closing machine and after closing machine adjustment (including adjustment for changes in container size).

(2) Teardown examinations. Teardown examinations of double seams formed by each closing machine head shall be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing head shall be examined on the packer's end during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, shall be promptly recorded by the closure technician. The establishment shall have container specification guidelines for double seam integrity on file and available for review by Program employees. A teardown examination of the can maker's end shall be performed on at least one container selected from each closing machine during each examination period except when teardown examinations are made on incoming empty containers or when, in the case of self-manufactured containers, the containers are made in the vicinity of the establishment and the container plant records are made available to Program employees. Additional teardown examinations on the packer's end should be made at the beginning of production, immediately following every jam in a closing machine and after closing machine adjustment (including adjustment for a change in container size). The following procedures shall be used in teardown examinations of double seams:

(i) One of the following two methods shall be employed for dimensional measurements of the double seam.

(a) Micrometer measurement. For cylindrical containers, measure the following dimensions (Figure 1) at three points approximately 120 degrees apart on the double seam excluding and at least one-half inch from the side seam juncture:

(1) Double seam length—W;

(2) Double seam thickness—S;

(3) Body hook length—BH; and

(4) Cover hook length—CH.

Maximum and minimum values for each dimensional measurement shall be recorded by the closure technician.

eCFR graphic ec11se91.046.gif

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(b) Seamscope or seam projector. Required measurements of the seam include thickness, body hook, and overlap. Seam thickness shall be obtained by micrometer. For cylindrical containers, at least two locations, excluding the side seam juncture, shall be used to obtain the required measurements.

(ii) Seam tightness. Regardless of the dimensional measurement method used to measure seam dimensions, at a minimum, the seam(s) examined shall be stripped to assess the degree of wrinkling.

(iii) Side seam juncture rating. Regardless of the dimensional measurement method used to measure seam dimensions, the cover hook shall be stripped to examine the cover hook droop at the juncture for containers having side seams.

(iv) Examination of noncylindrical containers. Examination of noncylindrical containers (e.g., square, rectangular, “D”-shaped, and irregularly-shaped) shall be conducted as described in paragraphs (b)(2) (i), (ii), and (iii) of this section except that the required dimensional measurements shall be made on the double seam at the points listed in the establishment's container specification guidelines.

(c) Closure examinations for glass containers—(1) Visual examinations. A closure technician shall visually assess the adequacy of the closures formed by each closing machine. When closure defects, such as loose or cocked caps, fractured or cracked containers and low vacuum jars, are observed, necessary corrective actions, such as adjusting or repairing the closing machine, shall be taken and recorded. In addition to the closures, the entire container shall be examined for defects. Visual examinations shall be made with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations shall be made by the closure technician and the observations recorded at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size).

(2) Closure examinations and tests. Depending upon the container and closure, tests shall be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made either before or after thermal processing and at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing machine shall be examined during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, shall be promptly recorded by the closure technician. The establishment shall have specification guidelines for closure integrity on file and available for review by Program employees. Additional closure examinations should be made at the beginning of production, immediately following every jam in the closing machine and after closing machine adjustment (including adjustment for a change in container size).

(d) Closure examinations for semirigid and flexible containers—(1) Heat seals—(i) Visual examinations. A closure technician shall visually examine the seals formed by each sealing machine. When sealing defects are observed, necessary corrective actions, such as adjusting or repairing the sealing machine, shall be taken and recorded. In addition to examining the heat seals, the entire container shall be examined for product leakage or obvious defects. Visual examinations shall be performed before and after the thermal processing operation with sufficient frequency to ensure proper closure. These examinations should be conducted at least in accordance with a statistical sampling plan. All defects noted and corrective actions taken shall be promptly recorded.

(ii) Physical tests. Tests determined by the establishment as necessary to assess container integrity shall be conducted by the closure technician at a frequency sufficient to ensure proper closure. These tests shall be performed after the thermal processing operation and should be made at least every 2 hours of continuous production. The establishment's acceptance guidelines for each test procedure shall be on file and available for review by Program employees. Test results along with any necessary corrective actions, such as adjusting or repairing the sealing machine, shall be recorded.

(2) Double seams on semirigid or flexible containers shall be examined and the results recorded as provided in paragraph (b) of this section. Any additional measurements specified by the container manufacturer shall also be made and recorded.

(e) Container coding. Each container shall be marked with a permanent, legible, identifying code mark. The mark shall, at a minimum, identify in code the product (unless the product name is lithographed or printed elsewhere on the container) and the day and year the product was packed.

(f) Handling of containers after closure. (1) Containers and closures shall be protected from damage which may cause defects that are likely to affect the hermetic condition of the containers. The accumulation of stationary containers on moving conveyors should be minimized to avoid damage to the containers.

(2) The maximum time lapse between closing and initiation of thermal processing shall be 2 hours. However, the Administrator may specify a shorter period of time when considered necessary to ensure product safety and stability. A longer period of time between closing and the initiation of thermal processing may be permitted by the Administrator.

(Approved by the Office of Management and Budget under control number 0583-0015)

§381.302   Thermal processing.

(a) Process schedules. Prior to the processing of canned product for distribution in commerce, an establishment shall have a process schedule (as defined in §381.300(n) of this subpart) for each canned poultry product to be packed by the establishment.

(b) Source of process schedules. (1) Process schedules used by an establishment shall be developed or determined by a processing authority.

(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 shall 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 shall 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, shall be made available by the establishment to the Program employee upon request.

(c) Submittal of process information. (1) Prior to the processing of canned product for distribution in commerce, the establishment shall provide the inspector at the establishment with a list of the process schedules (including alternate schedules) along with any additional applicable information, such as the retort come-up operating procedures and critical factors.

(2) Letters or other written communications from a processing authority recommending all process schedules shall be maintained on file by the establishment. Upon request by Program employees, the establishment shall make available such letters or written communications (or copies thereof). If critical factors are identified in the process schedule, the establishment shall 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 shall not be changed without the prior written submittal of the revised procedures (including supporting documentation) to the inspector at the establishment.

(Approved by the Office of Management and Budget under control number 0583-0015)

§381.303   Critical factors and the application of the process schedule.

Critical factors specified in the process schedule shall 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. (1) Maximum fill-in weight or drained weight;

(2) Arrangement of pieces in the container;

(3) Container orientation during thermal processing;

(4) Product formulation;

(5) Particle size;

(6) Maximum thickness for flexible, 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. (1) Minimum headspace; and

(2) Retort reel speed.

(c) Hydrostatic retorts. (1) Chain or conveyor speed.

(d) Steam/air retorts. (1) Steam/air ratio; and

(2) Heating medium flow rate.

(Approved by the Office of Management and Budget under control number 0583-0015)

§381.304   Operations in the thermal processing area.

(a) Posting of processes. Process schedules (or operating process schedules) for daily production, including minimum initial temperatures and operating procedures for thermal processing equipment, shall be posted in a conspicuous place near the thermal processing equipment. Alternatively, such information shall be available to the thermal processing system operator and the inspector.

(b) Process indicators and retort traffic control. A system for product traffic control shall be established to prevent product from bypassing the thermal processing operation. Each basket, crate or similar vehicle containing unprocessed product, or at least one visible container in each vehicle, shall be plainly and conspicuously marked with a heat sensitive indicator that will visually indicate whether such unit has been thermally processed. Exposed heat sensitive indicators attached to container vehicles shall be removed before such vehicles are refilled with unprocessed product. Container loading systems for crateless retorts shall be designed to prevent unprocessed product from bypassing the thermal processing operation.

(c) Initial temperature. The initial temperature of the contents of the coldest container to be processed shall be determined and recorded by the establishment at the time the processing cycle begins to assure that the temperature of the contents of every container to be processed is not lower than the minimum initial temperature specified in the process schedule. Thermal processing systems which subject the filled and sealed containers to water at any time before process timing begins shall be operated to assure that such water will not lower the temperature of the product below the minimum initial temperature specified in the process schedule.

(d) Timing devices. Devices used to time applicable thermal processing operation functions or events, such as process schedule time, come-up time and retort venting, shall be accurate to assure that all such functions or events are achieved. Pocket watches and wrist watches are not considered acceptable timing devices. Analog and digital clocks are considered acceptable. If such clocks do not display seconds, all required timed functions or events shall have at least a 1-minute safety factor over the specified thermal processing operation times. Temperature/time recording devices shall correspond within 15 minutes to the time of the day recorded on written records required by §381.306.

(e) Measurement of pH. Unless other methods are approved by the Administrator, potentiometric methods using electronic instruments (pH meters) shall be used for making pH determinations when a maximum pH value is specified as a critical factor in a process schedule.

§381.305   Equipment and procedures for heat processing systems.

(a) Instruments and controls common to different thermal processing systems—(1) Indicating temperature devices. Each retort shall be equipped with at least one indicating temperature device that measures the actual temperature within the retort. The indicating temperature device, not the temperature/time recording device, shall be used as the reference instrument for indicating the process temperature.

(i) Mercury-in-glass thermometers. A mercury-in-glass thermometer shall have divisions that are readable to 1 °F (or 0.5 °C) and whose scale contains not more than 17 °F/inch (or 4.0 °C/cm) of graduated scale. Each mercury-in-glass thermometer shall be tested for accuracy against a known accurate standard upon installation and at least once a year to ensure its accuracy. Records that specify the date, standard used, test method, and the person or testing authority performing the test shall be maintained on file by the establishment and made available to Program employees. A mercury-in-glass thermometer that has a divided mercury column or that cannot be adjusted to the standard shall be repaired and tested for accuracy before further use, or replaced.

(ii) Other devices. Temperature-indicating devices used in lieu of mercury-in-glass thermometers, such as resistance temperature detectors, shall meet known, accurate standards for such devices when tested for accuracy. The records of such testing shall be available to FSIS program employees.

(2) Temperature/time recording devices. Each thermal processing system shall be equipped with at least one temperature/time recording device to provide a permanent record of temperatures within the thermal processing system. This recording device may be combined with the steam controller and may be a recording/controlling instrument. When compared to the known accurate indicating temperature device, the recording accuracy shall be equal to or better than 1 °F (or 0.5 °C) at the process temperature. The temperature recording chart should be adjusted to agree with, but shall never be higher than, the known accurate indicating temperature device. A means of preventing unauthorized changes in the adjustment shall be provided. For example, a lock or a notice from management posted at or near the recording device warning that only authorized persons are permitted to make adjustments, are satisfactory means for preventing unauthorized changes. Air-operated temperature controllers shall have adequate filter systems to ensure a supply of clean, dry air. The recorder timing mechanism shall be accurate.

(i) Chart-type devices. Devices using charts shall be used only with the correct chart. Each chart shall have a working scale of not more than 55 °F/inch (or 12 °C/cm) within a range of 20 °F (or 11 °C) of the process temperature. Chart graduations shall not exceed 2 °F (or 1 °C) within a range of 10 °F (or 5 °C) of the process temperature. Multipoint plotting chart-type devices shall print temperature readings at intervals that will assure that the parameters of the process time and process temperature have been met. The frequency of recording should not exceed 1-minute intervals.

(ii) Other devices. Temperature/time recording devices or procedures used in lieu of chart-type devices must meet known accurate standards for such devices or procedures when tested for accuracy. Such a device must be accurate enough for ensuring that process time and temperature parameters have been met.

(3) Steam controllers. Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recording/controlling instrument when combined with a temperature/time recording device.

(4) Air valves. All air lines connected to the retorts designed for pressure processing in steam shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of air into the retort during the process cycle.

(5) Water valves. All retort water lines that are intended to be closed during a process cycle shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of water into the retort during the process cycle.

(b) Pressure processing in steam—(1) Batch still retorts. (i) The basic requirements and recommendations for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a 34 inch (1.9 cm) diameter opening and equipped with a 116 inch (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulb or probe. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort, and shall enter at a point to facilitate air removal during venting.

(iv) Crate supports. Vertical still retorts with bottom steam entry shall employ bottom retort crate supports. Baffle plates shall not be used in the bottom of retorts.

(v) Steam spreader. Perforated steam spreaders, if used, shall be maintained to ensure they are not blocked or otherwise inoperative. Horizontal still retorts shall be equipped with perforated steam spreaders that extend the full length of the retort unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority. Such information shall be maintained on file by the establishment and made available to Program employees for review.

(vi) Bleeders and condensate removal. Bleeders, except those for external wells of temperature devices, shall have 18 inch (or 3 mm) or larger openings and shall be wide open during the entire process including the come-up time. For horizontal still retorts, bleeders shall be located within approximately 1 foot (or 30 cm) of the outermost locations of containers at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged in a way that enables the retort operator to observe that they are functioning properly. Vertical retorts shall have at least one bleeder opening located in the portion of the retort opposite the steam inlet. All bleeders shall be arranged so that the retort operator can observe that they are functioning properly. In retorts having a steam inlet above the level of the lowest container, a bleeder shall be installed in the bottom of the retort to remove condensate. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.

(vii) Stacking equipment. (a) Equipment for holding or stacking containers in retorts. Crates, trays, gondolas, carts, and other vehicles for holding or stacking product containers in the retort shall be so constructed to ensure steam circulation during the venting, come-up, and process times. The bottom of each vehicle shall have perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) centers or the equivalent unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority and such information is maintained on file by the establishment and made available to Program employees for review.

(b) Divider plates. Whenever one or more divider plates are used between any two layers of containers or placed on the bottom of a retort vehicle, the establishment shall have on file documentation that the venting procedure allows the air to be removed from the retort before timing of the thermal process is started. Such documentation shall be in the form of heat distribution data or documentation from a processing authority. This information shall be made available to Program employees for review.

(viii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have on file documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information shall be made available to Program employees for review.

(ix) Vents. (a) Vents shall be located in that portion of the retort opposite the steam inlet and shall be designed, installed, and operated in such a way that air is removed from the retort before timing of the thermal process is started. Vents shall be controlled by a gate, plug cock, or other full-flow valve which shall be fully opened to permit rapid removal of air from retorts during the venting period.

(b) Vents shall 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 shall be controlled by a gate, plug cock, or other full-flow valve and the manifold shall 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 shall 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 shall lead to the atmosphere. The manifold header shall not be controlled by a valve and shall 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 shall be in the form of heat distribution data or other documentation from the equipment manufacturer or processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(d) For crateless retort installations, the establishment shall 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 shall 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) Venting through multiple 1 inch (2.5 cm) vents discharging directly to the atmosphere.

eCFR graphic ec11se91.047.gif

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Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length, equipped with a gate, plug cock, or other full-flow valve and discharging to atmosphere. The end vents shall not be more than 212 feet (or 75 cm) from ends of retort.

Venting method (Figure 1): Vent valves shall be wide open for at least 5 minutes and to at least 225 °F (or 107 °C), or at least 7 minutes and to at least 220 °F (or 104.5 °C).

(ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere.

eCFR graphic ec11se91.048.gif

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Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length; vents not over 212 feet (or 75 cm) from ends of retort; size of manifold for retorts less than 15 feet (4.6 m) in length, 212 inches (6.4 cm), and for retorts 15 feet (4.6 m) and over in length, 3 inches (7.6 cm).

Venting method (Figure 2): The manifold vent gate, plug cock, or other full-flow valve shall be wide open for at least 6 minutes and to at least 225 °F (or 107 °C) or for at least 8 minutes and to at least 220 °F (or 104.5 °C).

(iii) Venting through water spreaders.

eCFR graphic ec11se91.049.gif

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Specifications (Figure 3): Size of vent and vent valve. For retorts less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 feet (4.6 m) and over in length, 212 inches (6.4 cm).

Size of water spreader (Figure 3): For retorts less than 15 feet (4.6 m) in length, 112 inches (3.8 cm); for retorts 15 feet (4.6 m) and over in length 2 inches (or 5 cm). The number of holes shall be such that their total cross-sectional area is equal to the cross-sectional area of the vent pipe inlet.

Venting method (Figure 3): The gate, plug cock, or other full-flow valve on the water spreader vent shall be wide open for at least 5 minutes and to at least 225 °F (or 107 °C), or for at least 7 minutes and to at least 220 °F (or 104.5 °C).

(iv) Venting through a single 212 inch (6.4 cm) top vent for retorts not exceeding 15 feet (4.6 m) in length.

eCFR graphic ec11se91.050.gif

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Specifications (Figure 4): A 212 inch (6.4 cm) vent equipped with a 212 inch (6.4 cm) gate, plug cock, or other full-flow valve and located within 2 feet (61 cm) of the center of the retort.

Venting method (Figure 4): The vent valve shall be wide open for at least 4 minutes and to at least 220 °F (or 104.5 °C).

(2) Venting vertical retorts.

(i) Venting through a 112 inch (3.8 cm) overflow.

eCFR graphic ec11se91.051.gif

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Specifications (Figure 5): A 112 inch (3.8 cm) overflow pipe equipped with a 112 inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 112 inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header.

Venting method (Figure 5): The vent valve shall be wide open for at least 4 minutes and to at least 218 °F (or 103.5 °C), or for at least 5 minutes and to at least 215 °F (or 101.5 °C).

(ii) Venting through a single 1 inch (2.5 cm) side or top vent.

eCFR graphic ec11se91.052.gif

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Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or top side, equipped with a gate, plug cock, or other full-flow valve and discharging directly into the atmosphere or to a manifold header.

Venting method (Figure 6 or 7): The vent valve shall be wide open for at least 5 minutes and to at least 230 °F (110 °C), or for at least 7 minutes and to at least 220 °F (or 104.5 °C).

(2) Batch agitating retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a 34 inch (1.9 cm) diameter opening and equipped with a 116 (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort and shall enter at a point(s) to facilitate air removal during venting.

(iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be 18 inch (or 3 mm) or larger and shall be wide open during the entire process including the come-up time. Bleeders shall be located within approximately 1 foot (or 30 cm) of the outermost location of containers, at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or from a processing authority that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged in a way that enables the retort operator to observe that they are functioning properly.

(v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who developed the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the retort to remove condensate during retort operation. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.

(vi) Retort or reel speed timing. The retort or reel speed shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(vii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(3) Continuous rotary retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a 34 inch (1.9 cm) diameter opening and equipped with a 116 inch (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort, and shall enter at a point(s) to facilitate air removal during venting.

(iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be 18 inch (3.2 mm) or larger and shall be wide open during the entire process, including the come-up time. Bleeders shall be located within approximately 1 foot (or 30 cm) of the outermost location of containers at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top of the retort. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or a processing authority that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged so that the retort operator can observe that they are functioning properly.

(v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who developed the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the shell to remove condensate during the retort operation. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.

(vi) Retort speed timing. The rotational speed of the retort shall be specified in the process schedule. The speed shall be adjusted as specified, and recorded by the establishment when the retort is started, and checked and recorded at intervals not to exceed 4 hours to ensure that the correct retort speed is maintained. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. If a recording tachometer is used, the speed shall be manually checked against an accurate stopwatch at least once per shift and the results recorded. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(vii) Bleeders and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or other documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(4) Hydrostatic retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, indicating temperature devices shall be located in the steam dome near the steam/water interface. Where the process schedule specifies maintenance of particular water temperatures in the hydrostatic water legs, at least one indicating temperature device shall be located in each hydrostatic water leg so that it can accurately measure water temperature and be easily read. The temperature/time recorder probe shall be installed either within the steam dome or in a well attached to the dome. Each probe shall have a 116 inch (1.6 mm) or larger bleeder opening which emits steam continuously during the processing period. Additional temperature/time recorder probes shall be installed in the hydrostatic water legs if the process schedule specifies maintenance of particular temperatures in these water legs.

(ii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlets shall be large enough to provide steam for proper operation of the retort.

(iv) Bleeders. Bleeder openings 14 inch (or 6 mm) or larger shall be located in the steam chamber(s) opposite the point of steam entry. Bleeders shall be wide open and shall emit steam continuously during the entire process, including the come-up time. All bleeders shall be arranged in such a way that the operator can observe that they are functioning properly.

(v) Venting. Before the start of processing operations, the retort steam chamber(s) shall be vented to ensure removal of air. Heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the air is removed from the retort prior to processing shall be kept on file at the establishment and made available to Program employees for review.

(vi) Conveyor speed. The conveyor speed shall be calculated to obtain the required process time and recorded by the establishment when the retort is started. The speed shall be checked and recorded at intervals not to exceed 4 hours to ensure that the correct conveyor speed is maintained. A recording device may be used to provide a continuous record of the conveyor speed. When a recording device is used, the speed shall be manually checked against an accurate stopwatch at least once per shift by the establishment. A means of preventing unauthorized speed changes of the conveyor shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(vii) Bleeders and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or other documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(c) Pressure processing in water—(1) Batch still retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a)(1) and (2) of this section. Additionally, bulbs or probes of indicating temperature devices shall be located in such a position that they are beneath the surface of the water throughout the process. On horizontal retorts, the indicating temperature device bulb or probe shall be inserted directly into the retort shell. In both vertical and horizontal retorts, the indicating temperature device bulb or probe shall extend directly into the water a minimum of 2 inches (or 5 cm) without a separable well or sleeve. In vertical retorts equipped with a recorder/controller, the controller probe shall be located at the bottom of the retort below the lowest crate rest in such a position that the steam does not strike it directly. In horizontal retorts so equipped, the controller probe shall be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for direct steam impingement on the controller probe. Air-operated temperature controllers shall have filter systems to ensure a supply of clean, dry air.

(ii) Pressure recording device. Each retort shall be equipped with a pressure recording device which may be combined with a pressure controller.

(iii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority demonstrating uniform heat distribution within the retort shall be kept on file at the establishment and made available to Program employees for review.

(v) Crate supports. A bottom crate support shall be used in vertical retorts. Baffle plates shall not be used in the bottom of the retort.

(vi) Stacking equipment. For filled flexible containers and, where applicable, semirigid containers, stacking equipment shall be designed to ensure that the thickness of the filled containers does not exceed that specified in the process schedule and that the containers do not become displaced and overlap or rest on one another during the thermal process.

(vii) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings.

(viii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). For retorts requiring complete immersion of containers, water shall cover the top layer of containers during the entire come-up time and thermal processing periods and should cover the top layer of containers during cooling. For retorts using cascading water or water sprays, the water level shall be maintained within the range specified by the retort manufacturer or processing authority during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the water level at intervals to ensure it meets the specified processing parameters.

(ix) Air supply and controls. In both horizontal and vertical still retorts, a means shall be provided for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it shall be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review.

(x) Water recirculation. When a water recirculation system is used for heat distribution, the water shall be drawn from the bottom of the retort through a suction manifold and discharged through a spreader that extends the length or circumference of the top of the retort. The holes in the water spreader shall be uniformly distributed. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running, and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used, provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.

(xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.

(2) Batch agitating retorts. (i) The basic requirements and recommendations for indicating temperature devices and temperture/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, the indicating temperature device bulb or probe shall extend directly into the water without a separable well or sleeve. The recorder/controller probe shall be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for steam to directly strike the controller bulb or probe.

(ii) Pressure recording device. Each retort shall be equipped with a pressure recording device which may be combined with a pressure controller.

(iii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority shall be kept on file by the establishment and made available to Program employees for review.

(v) Stacking equipment. All devices used for holding product containers (e.g., crates, trays, divider plates) shall be so constructed to allow the water to circulate around the containers during the come-up and thermal process periods.

(vi) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings.

(vii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). Water shall completely cover all containers during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the adequacy of the water level with sufficient frequency to ensure it meets the specified processing parameters.

(viii) Air supply and controls. Retorts shall be provided with a means for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it shall be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review.

(ix) Retort or reel speed timing. The retort or reel speed timing shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by the establishment by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(x) Water recirculation. If a water recirculation system is used for heat distribution, it shall be installed in such a manner that water will be drawn from the bottom of the retort through a suction manifold and discharged through a spreader which extends the length of the top of the retort. The holes in the water spreader shall be uniformly distributed. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.

(xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.

(d) Pressure processing with steam/air mixtures in batch retorts. (1) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes for indicating temperature devices and temperature/time recording devices or controller probes shall be inserted directly into the retort shell in such a position that steam does not strike them directly.

(2) Steam controllers are required as described in paragraph (a)(3) of this section.

(3) Recording pressure controller. A recording pressure controller shall be used to control the air inlet and the steam/air mixture outlet.

(4) Circulation of steam/air mixture. A means shall be provided for the circulation of the steam/air mixture to prevent formation of low-temperature pockets. The efficiency of the circulation system shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. The circulation system shall be checked to ensure its proper functioning and shall be equipped with a pilot light or a similar device to warn the operator when it is not functioning. Because of the variety of existing designs, reference shall be made to the equipment manufacturer for details of installation, operation and control.

(e) Atmospheric cookers—(1) Temperature/time recording device. Each atmospheric cooker (e.g., hot water bath) shall be equipped with at least one temperature/time recording device in accordance with the basic requirements described in paragraph (a)(2) of this section.

(2) Heat distribution. Each atmospheric cooker shall be equipped and operated to ensure uniform heat distribution throughout the processing system during the thermal process. Heat distribution data or other documentation from the manufacturer or a processing authority demonstrating uniform heat distribution within the cooker shall be kept on file by the establishment and made available to Program employees for review.

(f) Other systems. All other systems not specifically delineated in this section and used for the thermal processing of canned product shall be adequate to produce shelf-stable products consistently and uniformly.

(g) Equipment maintenance. (1) Upon installation, all instrumentation and controls shall be checked by the establishment for proper functioning and accuracy and, thereafter, at any time their functioning or accuracy is suspect.

(2) At least once a year each thermal processing system shall 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 shall be checked by the establishment for leaks. Defective valves shall be repaired or replaced as needed.

(4) Vent and bleeder mufflers shall be checked and maintained or replaced by the establishment to prevent any reduction in vent or bleeder efficiency.

(5) When water spreaders are used for venting, a maintenance schedule shall be developed and implemented to assure that the holes are maintained at their original size.

(6) Records shall be kept on all maintenance items that could affect the adequacy of the thermal process. Records shall include the date and type of maintenance performed and the person conducting the maintenance.

(h) Container cooling and cooling water. (1) Potable water shall be used for cooling except as provided for in paragraphs (h) (2) and (3) of this section.

(2) Cooling canal water shall be chlorinated or treated with a chemical approved by the Administrator as having a bactericidal effect equivalent to chlorination. There shall be a measurable residual of the sanitizer in the water at the discharge point of the canal. Cooling canals shall 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 shall 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, shall be constructed and installed so that they can be cleaned and inspected. In addition, the establishment shall 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. Containers shall be handled in a manner that will prevent damage to the hermetic seal area. All worn and frayed belting, can retarders, cushions, and the like shall be replaced with nonporous materials. To minimize container abrasions, particularly in the seal area, containers should not remain stationary on moving conveyors. All post-process container handling equipment should be kept clean so there is no buildup of microorganisms on surfaces in contact with the containers.

(Approved by the Office of Management and Budget under control number 0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000]

§381.306   Processing and production records.

At least the following processing and production information shall 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 §381.303 regarding the control of critical factors shall be recorded. In addition, where applicable, the following information and data shall also be recorded:

(a) Processing in steam—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or the number of retort crates per retort load, product initial temperature, time steam on, the time and temperature vent closed, the start of process timing, time steam off, and the actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(2) Batch agitating retorts. In addition to recording the information required for batch, still steam retorts in paragraph (a)(1) of this section, record the functioning of the condensate bleeder(s) and the retort or reel speed.

(3) Continuous rotary retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent closed, time process temperature reached, the time the first can enters and the time the last can exits the retort. The retort or reel speed shall be determined and recorded at intervals not to exceed 4 hours. Readings of the indicating temperature device(s) and temperature recorder(s) shall be made and recorded at the time the first container enters the retort and thereafter with sufficient frequency to ensure compliance with the process schedule. These observations should be made and recorded at intervals not exceeding 30 minutes of continuous retort operation. Functioning of the condensate bleeder(s) shall be observed and recorded at the time the first container enters the retort and thereafter as specified in §381.305(b)(3)(v).

(4) Hydrostatic retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent(s) closed, time process temperature reached, time first containers enter the retort, time last containers exit the retort, and, if specified in the process schedule, measurements of temperatures in the hydrostatic water legs. Readings of the temperature indicating device, which is located in the steam/water interface, and the temperature recording device shall be observed and the temperatures recorded at the time the first containers enter the steam dome. Thereafter, these instruments shall be read and the temperatures recorded with sufficient frequency to ensure compliance with the temperature specified in the process schedule and should be made at least every hour of continuous retort operation. Container conveyor speed, and for agitating hydrostatic retorts, the rotative chain speed, shall be determined and recorded at intervals of sufficient frequency to ensure compliance with the process schedule and should be performed at least every 4 hours.

(b) Processing in water—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, the start of process timing, water level, water recirculation rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(2) Batch agitating retorts. In addition to recording the information required in paragraph (b)(1) of this section, record the retort or reel speed.

(c) Processing in steam/air mixtures. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, venting procedure, if applicable, the start of process timing, maintenance of circulation of the steam/air mixture, air flow rate or forced recirculation flow rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(d) Atmospheric cookers—(1) Batch-type systems. For each cooker batch, record the cooker number or other designation and the approximate number of containers. In addition, record all critical factors of the process schedule such as cooker temperature, initial temperature, the time the thermal process cycle begins and ends, hold time, and the final internal product temperature.

(2) Continuous-type systems. Record the cooker number or other designation, the time the first containers enter and the last containers exit a cooker, and the approximate total number of containers processed. In addition, record all critical factors of the process schedule such as the initial temperature, cooker speed, and final internal product temperature.

(Approved by the Office of Management and Budget under control number 0583-0015)

§381.307   Record review and maintenance.

(a) Process records. Charts from temperature/time recording devices shall be identified by production date, container code, processing vessel number or other designation and other data as necessary to enable correlation with the records required in §381.306. Each entry on a record shall be made at the time the specific event occurs, and the recording individual shall sign or initial each record form. No later than 1 working day after the actual process, the establishment shall review all processing and production records to ensure completeness and to determine if all product received the process schedule. All records, including the temperature/time recorder charts and critical factor control records, shall be signed or initialed and dated by the person conducting the review. All processing and production records required in this subpart shall be made available to Program employees for review.

(b) Automated process monitoring and recordkeeping. Automated process monitoring and recordkeeping systems shall be designed and operated in a manner which will ensure compliance with the applicable requirements of §381.306.

(c) Container closure records. Written records of all container closure examinations shall specify the container code, the date and time of container closure examination, the measurement(s) obtained, and any corrective actions taken. Records shall be signed or initialed by the container closure technician and shall be reviewed and signed by the establishment within 1 working day after the actual production to ensure that the records are complete and that the closing operations have been properly controlled. All container closure examination records required in this subpart shall be made available to Program employees for review.

(d) Distribution of product. Records shall be maintained by the establishment identifying initial distribution of the finished product to facilitate, if necessary, the segregation of specific production lots that may have been contaminated or are otherwise unsound for their intended use.

(e) Retention of records. Copies of all processing and production records required in §381.306 shall be retained for no less than 1 year at the establishment, and for an additional 2 years at the establishment or other location from which the records can be made available to Program employees within 3 working days.

(Approved by the Office of Management and Budget under control number 0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000]

§381.308   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 shall be considered a deviation in processing.

(b) Deviations in processing (or process deviations) must be handled according to:

(1)(i) A HACCP plan for canned product that addresses hazards associated with microbial contamination, or,

(ii) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or

(iii) Paragraph (d) of this section.

(2) Paragraph (d) of this section.

(c) [Reserved]

(d) 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. If a deviation is noted at any time before the completion of the intended process schedule, the establishment shall:

(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 §381.302 (a) and (b) and is filed with the inspector in accordance with §381.302(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 shall 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 (d)(1)(iii) of this section shall 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 shall be set aside for further evaluation in accordance with paragraphs (d)(1) (iii) and (iv) of this section.

(vi) When a deviation occurs in a continuous rotary retort, the product shall be handled in accordance with paragraphs (d)(1) (iii) and (iv) of this section or in accordance with the following procedures:

(a) Emergency stops.

(1) When retort jams or breakdowns occur during the processing operations, all containers shall be given an emergency still process (developed per §381.302(b)) before the retort is cooled or the retort shall be cooled promptly and all containers removed and either reprocessed, repacked and reprocessed, or destroyed. Regardless of the procedure used, containers in the retort intake valve and in transfer valves between retort shells at the time of a jam or breakdown shall be removed and either reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in §301.2(ee) of this chapter, and disposed of in accordance with part 314 of this chapter.

(2) The time the retort reel stopped and the time the retort is used for an emergency still retort process shall be noted on the temperature/time recording device and entered on the other production records required in §381.306.

(b) Temperature drops. When the retort temperature drops below the temperature specified in the process schedule, the reel shall be stopped and the following actions shall be taken:

(1) For temperature drops of less than 10 °F (or 5.5 °C) either (i) all containers in the retort shall be given an emergency still process (developed per §381.302(b)) before the reel is restarted; (ii) container entry to the retort shall be prevented and an emergency agitating process (developed per §381.302(b)) shall be used before container entry to the retort is restarted; or (iii) container entry to the retort shall be prevented and the reel restarted to empty the retort. The discharged containers shall be reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in §301.2(ee) of this chapter, and disposed of in accordance with part 314 of this chapter.

(2) For temperature drops of 10 °F (or 5.5 °C) or more, all containers in the retort shall be given an emergency still process (developed per §381.302(b)). The time the reel was stopped and the time the retort was used for a still retort process shall be marked on the temperature/time recording device by the establishment and entered on the other production records required in §381.306. Alternatively, container entry to the retort shall be prevented and the reel restarted to empty the retort. The discharged containers shall be either reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned” as defined in §301.2(ee) of this chapter, and disposed of in accordance with part 314 of this chapter.

(2) Deviations identified through record review. Whenever a deviation is noted during review of the processing and production records required by §381.307 (a) and (b), the establishment shall hold the product involved and the deviation shall be handled in accordance with paragraphs (d)(1) (iii) and (iv) of this section.

(e) Process deviation file. The establishment shall maintain full records regarding the handling of each deviation. Such records shall include, at a minimum, the appropriate processing and production records, a full description of the corrective actions taken, the evaluation procedures and results, and the disposition of the affected product. Such records shall be maintained in a separate file or in a log that contains the appropriate information. The file or log shall be retained in accordance with §381.307(e) and shall be made available to Program employees upon request.

(Approved by the Office of Management and Budget under control number 0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 62 FR 45027, Aug. 25, 1997; 65 FR 34390, May 30, 2000; 65 FR 53533, Sept. 5, 2000]

§381.309   Finished product inspection.

(a) Finished product inspections must be handled according to:

(1) A HACCP plan for canned product that addresses hazards associated with microbiological contamination; or

(2) An FSIS-approved total quality control system; or

(3) Alternative documented procedures that will ensure that only product that is safe and stable is shipped in commerce; or

(4) Paragraph (d) of this section.

(b)-(c) [Reserved]

(d) Procedures for 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 product—(i) Incubator. The establishment shall provide incubation facilities which include an accurate temperature/time recording device, an indicating temperature device, a means for the circulation of the air inside the incubator to prevent temperature variations, and a means to prevent unauthorized entry into the facility. The Program is responsible for the security of the incubator.

(ii) Incubation temperature. The incubation temperature shall be maintained at 95±5 °F (35±2.8 °C). If the incubation temperature falls below 90 °F (or 32 °C) or exceeds 100 °F (or 38 °C) but does not reach 103 °F (or 39.5 °C), the incubation temperature shall be adjusted within the required range and the incubation time extended for the time the sample containers were held at the deviant temperature. If the incubation temperature is at or above 103 °F (or 39.5 °C) for more than 2 hours, the incubation test(s) shall be terminated, the temperature lowered to within the required range, and new sample containers incubated for the required time.

(iii) Product requiring incubation. Shelf stable product requiring incubation includes:

(a) Low acid products as defined in §381.300(m); and

(b) Acidified low acid products as defined in §381.300(b).

(iv) Incubation samples. (a) From each load of product processed in a batch-type thermal processing system (still or agitation), the establishment shall select at least one container for incubation.

(b) For continuous rotary retorts, hydrostatic retorts, or other continuous-type thermal processing systems, the establishment shall select at least one container per 1,000 for incubation.

(c) Only normal-appearing containers shall be selected for incubation.

(v) Incubation time. Canned product requiring incubation shall be incubated for not less than 10 days (240 hours) under the conditions specified in paragraph (d)(1)(ii) of this section.

(vi) Incubation checks and record maintenance. Designated establishment employees shall visually check all containers under incubation each working day and the inspector shall be notified when abnormal containers are detected. All abnormal containers should be allowed to cool before a final decision on their condition is made. For each incubation test the establishment shall record at least the product name, container size, container code, number of containers incubated, in and out dates, and incubation results. The establishment shall retain such records, along with copies of the temperature/time recording charts, in accordance with §381.307(e).

(vii) Abnormal containers. The finding of abnormal containers (as defined in §381.300(a)) among incubation samples is cause to officially retain at least the code lot involved.

(viii) Shipping. No product shall be shipped from the establishment before the end of the required incubation period except as provided in this paragraph or paragraph (b) or (c) of this section. An establishment wishing to ship product prior to the completion of the required incubation period shall submit a written proposal to the area supervisor. Such a proposal shall include provisions that will assure that shipped product will not reach the retail level of distribution before sample incubation is completed and that product can be returned promptly to the establishment should such action be deemed necessary by the incubation test results. Upon receipt of written approval from the area supervisor, product may be routinely shipped provided the establishment continues to comply with all requirements of this subpart.

(2) Container condition. (i) Normal containers. Only normal-appearing containers shall be shipped from an establishment as determined by an appropriate sampling plan or other means acceptable to Program employees.

(ii) Abnormal containers. When abnormal containers are detected by any means other than incubation, the establishment shall inform the inspector and the affected code lot(s) shall not be shipped until the Program has determined that the product is safe and stable. Such a determination will take into account the cause and level of abnormals in the affected lot(s) as well as any product disposition actions either taken or proposed by the establishment.

(Approved by the Office of Management and Budget under control number 0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, 1992; 62 FR 45027, Aug. 25, 1997; 65 FR 34391, May 30, 2000; 65 FR 53533, Sept. 5, 2000]

§381.310   Personnel and training.

All operators of thermal processing systems specified in §381.305 and container closure technicians shall 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.

[51 FR 45634, Dec. 19, 1986]

§381.311   Recall procedure.

Establishments shall prepare and maintain a current procedure for the recall of all canned product covered by this subpart. Upon request, the recall procedure shall be made available to Program employees for review.

(Approved by the Office of Management and Budget under control number 0583-0015)



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