Food Safety and Inspection Service, USDA § 318.300

Subparts B–F [Reserved] (i) Headspace. That portion of a con- tainer not occupied by the product. Subpart G—Canning and Canned (1) Gross headspace. The vertical dis- Products tance between the level of the product (generally the liquid surface) in an up- right rigid container and the top edge SOURCE: 51 FR 45619, Dec. 19, 1986, unless of the container (i.e., the flange of an otherwise noted. unsealed can, the top of the double § 318.300 Definitions. seam on a sealed can, or the top edge of an unsealed jar). (a) Abnormal container. A container (2) Net headspace. The vertical dis- with any sign of swelling or product tance between the level of the product leakage or any evidence that the con- (generally the liquid surface) in an up- tents of the unopened container may be right rigid container and the inside spoiled. surface of the lid. (b) Acidified low acid product. A (j) Hermetically sealed containers. Air- canned product which has been formu- tight containers which are designed lated or treated so that every compo- and intended to protect the contents nent of the finished product has a pH of against the entry of microorganisms 4.6 or lower within 24 hours after the during and after thermal processing. completion of the thermal process un- less data are available from the estab- (1) Rigid container. A container, the lishment’s processing authority dem- shape or contour of which, when filled onstrating that a longer time period is and sealed, is neither affected by the safe. enclosed product nor deformed by ex- ternal mechanical pressure of up to 10 (c) Bleeders. Small orifices on a retort pounds per square inch gauge (0.7 kg/ through which steam, other gasses, and cm2) (i.e., normal firm finger pressure). condensate are emitted from the retort throughout the entire thermal process. (2) Semirigid container. A container, (d) Canned product. A meat food prod- the shape or contour of which, when uct with a water activity above 0.85 filled and sealed, is not significantly which receives a thermal process either affected by the enclosed product under before or after being packed in a her- normal atmospheric temperature and metically sealed container. Unless oth- pressure, but can be deformed by exter- erwise specified, the term ‘‘product’’ as nal mechanical pressure of less than 10 used in this subpart G shall mean pounds per square inch gauge (0.7 kg/ 2 ‘‘canned product.’’ cm ) (i.e., normal firm finger pressure). (e) Closure technician. The indi- (3) Flexible container. A container, the vidual(s) identified by the establish- shape or contour of which, when filled ment as being trained to perform spe- and sealed, is significantly affected by cific container integrity examinations the enclosed product. as required by this subpart and des- (k) Incubation tests. Tests in which ignated by the establishment to per- the thermally processed product is form such examinations. kept at a specific temperature for a (f) Code lot. All production of a par- specified period of time in order to de- ticular product in a specific size con- termine if outgrowth of microorga- tainer marked with a specific con- nisms occurs. tainer code. (l) Initial temperature. The tempera- (g) Come-up time. The elapsed time, ture, determined at the initiation of a including venting time (if applicable), thermal process cycle, of the contents between the introduction of the heat- of the coldest container to be proc- ing medium into a closed retort and essed. the start of process timing. (m) Low acid product. A canned prod- (h) Critical factor. Any characteristic, uct in which any component has a pH condition or aspect of a product, con- value above 4.6. tainer, or procedure that affects the (n) Process schedule. The thermal adequacy of the process schedule. Crit- process and any specified critical fac- ical factors are established by proc- tors for a given canned product re- essing authorities. quired to achieve shelf stability.

273 § 318.301 9 CFR Ch. III (1–1–14 Edition)

(o) Process temperature. The minimum the vapor pressure of pure water at the temperature(s) of the heating medium same temperature. to be maintained as specified in the process schedule. § 318.301 Containers and closures. (p) Process time. The intended time(s) (a) Examination and cleaning of empty a container is to be exposed to the containers. (1) Empty containers, clo- heating medium while the heating me- sures, and flexible pouch roll stock dium is at or above the process tem- shall be evaluated by the establish- perature(s). ment to ensure that they are clean and (q) Processing authority. The person(s) free of structural defects and damage or organization(s) having expert knowl- that may affect product or container edge of thermal processing require- integrity. Such an examination should ments for foods in hermetically sealed be based upon a statistical sampling containers, having access to facilities plan. for making such determinations, and (2) All empty containers, closures, designated by the establishment to per- and flexible pouch roll stock shall be form certain functions as indicated in stored, handled, and conveyed in such a this subpart. manner that will prevent soiling and (r) Program employee. Any inspector damage that could affect the hermetic or other individual employed by the condition of the sealed container. Department or any cooperating agency (3) Just before filling, rigid con- who is authorized by the Secretary to tainers shall be cleaned to prevent in- do any work or perform any duty in corporation of foreign matter into the connection with the Program (see finished product. Closures, semirigid § 301.2(f)). containers, preformed flexible pouches, (s) Retort. A pressure vessel designed and flexible pouch roll stock contained for thermal processing of product in original wrappings do not need to be packed in hermetically sealed con- cleaned before use. tainers. (b) Closure examinations for rigid con- (t) Seals. Those parts of a semirigid tainers (cans)—(1) Visual examinations. A container and lid or of a flexible con- closure technician shall visually exam- tainer that are fused together in order ine the double seams formed by each to hermetically close the container. closing machine head. When seam de- (u) Shelf stability. The condition fects (e.g., cutovers, sharpness, achieved by application of heat, suffi- knocked down flanges, false seams, cient, alone or in combination with droops) are observed, necessary correc- other ingredients and/or treatments, to tive actions, such as adjusting or re- render the product free of microorga- pairing the closing machine, shall be nisms capable of growing in the prod- taken. In addition to the double seams, uct at nonrefrigerated conditions (over the entire container shall be examined ° ° 50 F or 10 C) at which the product is for product leakage or obvious defects. intended to be held during distribution A visual examination shall be per- and storage. Shelf stability and shelf formed on at least one container from stable are synonymous with commer- each closing machine head, and the ob- cial sterility and commercially sterile, servations, along with any corrective respectively. actions, shall be recorded. Visual ex- (v) Thermal process. The heat treat- aminations shall be conducted with ment necessary to achieve shelf sta- sufficient frequency to ensure proper bility as determined by the establish- closure and should be conducted at ment’s processing authority. It is least every 30 minutes of continuous quantified in terms of: closing machine operation. Additional (1) Time(s) and temperature(s); or visual examinations shall be made by (2) Minimum product temperature. the closure technician at the beginning (w) Venting. The removal of air from of production, immediately following a retort before the start of process tim- every jam in the closing machine and ing. after closing machine adjustment (in- (x) Water activity. The ratio of the cluding adjustment for changes in con- water vapor pressure of the product to tainer size).

274 Food Safety and Inspection Service, USDA § 318.301

(2) Teardown examinations. Teardown the establishment and the container examinations of double seams formed plant records are made available to by each closing machine head shall be Program employees. Additional tear- performed by a closure technician at a down examinations on the packer’s end frequency sufficient to ensure proper should be made at the beginning of pro- closure. These examinations should be duction, immediately following every made at intervals of not more than 4 jam in a closing machine and after hours of continuous closing machine closing machine adjustment (including operation. At least one container from adjustment for a change in container each closing head shall be examined on size). The following procedures shall be the packer’s end during each regular used in teardown examinations of dou- examination period. Examination re- ble seams: sults along with any necessary correc- (i) One of the following two methods tive actions, such as adjusting or re- shall be employed for dimensional pairing the closing machine, shall be measurements of the double seam. promptly recorded by the closure tech- (a) Micrometer measurement. For cylin- nician. The establishment shall have drical containers, measure the fol- container specification guidelines for lowing dimensions (Figure 1) at three double seam integrity on file and avail- points approximately 120 degrees apart able for review by Program employees. on the double seam excluding and at A teardown examination of the can least one-half inch from the side seam maker’s end shall be performed on at juncture: least one container selected from each (1) Double seam length—W; closing machine during each examina- (2) Double seam thickness—S; tion period except when teardown ex- (3) Body hook length—BH; and aminations are made on incoming (4) Cover hook length—CH. empty containers or when, in the case Maximum and minimum values for of self-manufactured containers, the each dimensional measurement shall containers are made in the vicinity of be recorded by the closure technician.

275 § 318.301 9 CFR Ch. III (1–1–14 Edition)

(b) Seamscope or seam projector. Re- imum, the seam(s) examined shall be quired measurements of the seam in- stripped to assess the degree of wrin- clude thickness, body hook, and over- kling. lap. Seam thickness shall be obtained (iii) Side seam juncture rating. Regard- by micrometer. For cylindrical con- less of the dimensional measurement tainers, at least two locations, exclud- method used to measure seam dimen- ing the side seam juncture, shall be sions, the cover hook shall be stripped used to obtain the required measure- to examine the cover hook droop at the ments. juncture for containers having side (ii) Seam tightness. Regardless of the seams. dimensional measurement method used (iv) Examination of noncylindrical con- to measure seam dimensions, at a min- tainers. Examination of noncylindrical 276 Food Safety and Inspection Service, USDA § 318.301 containers (e.g., square, rectangular, after closing machine adjustment (in- ‘‘D’’-shaped, and irregularly-shaped) cluding adjustment for a change in shall be conducted as described in para- container size). graphs (b)(2) (i), (ii), and (iii) of this (d) Closure examinations for semirigid section except that the required dimen- and flexible containers—(1) Heat seals— sional measurements shall be made on (i) Visual examinations. A closure tech- the double seam at the points listed in nician shall visually examine the seals the establishment’s container speci- formed by each sealing machine. When fication guidelines. sealing defects are observed, necessary (c) Closure examinations for glass con- corrective actions, such as adjusting or tainers—(1) Visual examinations. A clo- repairing the sealing machine, shall be sure technician shall visually assess taken and recorded. In addition to ex- the adequacy of the closures formed by amining the heat seals, the entire con- each closing machine. When closure de- tainer shall be examined for product fects, such as loose or cocked caps, leakage or obvious defects. Visual ex- fractured or cracked containers and aminations shall be performed before low vacuum jars, are observed, nec- and after the thermal processing oper- essary corrective actions, such as ad- ation and with sufficient frequency to justing or repairing the closing ma- ensure proper closure. These examina- chine shall be taken and recorded. In tions should be conducted at least in addition to the closures, the entire accordance with a statistical sampling container shall be examined for de- plan. All defects noted and corrective fects. Visual examinations shall be actions taken shall be promptly re- made with sufficient frequency to en- corded. sure proper closure and should be con- (ii) Physical tests. Tests determined ducted at least every 30 minutes of con- by the establishment as necessary to tinuous closing machine operation. Ad- assess container integrity shall be con- ditional visual examinations shall be ducted by the closure technician at a made by the closure technician and the frequency sufficient to ensure proper observations recorded at the beginning closure. These tests shall be performed of production, immediately following after the thermal processing operation every jam in the closing machine, and and should be made at least every 2 after closing machine adjustment (in- hours of continuous production. The cluding adjustment for a change in establishment’s acceptance guidelines container size). for each test procedure shall be on file (2) Closure examinations and tests. De- and available for review by Program pending upon the container and clo- employees. Test results along with any sure, tests shall be performed by a clo- necessary corrective actions, such as sure technician at a frequency suffi- adjusting or repairing the sealing ma- cient to ensure proper closure. These chine, shall be recorded. examinations should be made either (2) Double seams on semirigid or before or after thermal processing and flexible containers shall be examined at intervals of not more than 4 hours of and the results recorded as provided in continuous closing machine operation. paragraph (b) of this section. Any addi- At least one container from each clos- tional measurements specified by the ing machine shall be examined during container manufacturer shall also be each regular examination period. Ex- made and recorded. amination results along with any nec- (e) Container coding. Each container essary corrective actions, such as ad- shall be marked with a permanent, leg- justing or repairing the closing ma- ible, identifying code mark. The mark chine, shall be promptly recorded by shall, at a minimum, identify in code the closure technician. The establish- the product (unless the product name ment shall have specification guide- lithographed or printed elsewhere on lines for closure integrity on file and the container) and the day and year available for review by Program em- the product was packed. ployees. Additional closure examina- (f) Handling of containers after closure. tions should be made at the beginning (1) Containers and closures shall be of production, immediately following protected from damage which may every jam in the closing machine, and cause defects that are likely to affect

277 § 318.302 9 CFR Ch. III (1–1–14 Edition) the hermetic condition of the con- the retort come-up operating proce- tainers. The accumulation of sta- dures and critical factors. tionary containers on moving con- (2) Letters or other written commu- veyors should be minimized to avoid nications from a processing authority damage to the containers. recommending all process schedules (2) The maximum time lapse between shall be maintained on file by the es- closing and initiation of thermal proc- tablishment. Upon request by Program essing shall be 2 hours. However, the employees, the establishment shall Administrator may specify a shorter make available such letters or written period of time when considered nec- communications (or copies thereof). If essary to ensure product safety and critical factors are identified in the stability. A longer period of time be- process schedule, the establishment tween closing and the initiation of shall provide the inspector with a copy thermal processing may be permitted of the procedures for measuring, con- by the Administrator. trolling, and recording these factors, along with the frequency of such meas- (Approved by the Office of Management and urements, to ensure that the critical Budget under control number 0583–0015) factors remain within the limits used § 318.302 Thermal processing. to establish the process schedule. Once submitted, the process schedules and (a) Process schedules. Prior to the associated critical factors and the pro- processing of canned product for dis- cedures for measuring (including the tribution in commerce, an establish- frequency), controlling, and recording ment shall have a process schedule (as of critical factors shall not be changed defined in § 318.300(n) of this subpart) without the prior written submittal of for each canned meat product to be the revised procedures (including sup- packed by the establishment. porting documentation) to the inspec- (b) Source of process schedules. (1) tor at the establishment. Process schedules used by an establish- ment shall be developed or determined (Approved by the Office of Management and by a processing authority. Budget under control number 0583–0015) (2) Any change in product formula- § 318.303 Critical factors and the appli- tion, ingredients, or treatments that cation of the process schedule. are not already incorporated in a proc- ess schedule and that may adversely af- Critical factors specified in the proc- fect either the product heat penetra- ess schedule shall be measured, con- tion profile or sterilization value re- trolled and recorded by the establish- quirements shall be evaluated by the ment to ensure that these factors re- establishment’s processing authority. main within the limits used to estab- If it is determined that any such lish the process schedule. Examples of change adversely affects the adequacy factors that are often critical to proc- of the process schedule, the processing ess schedule adequacy may include: authority shall amend the process (a) General. (1) Maximum fill-in schedule accordingly. weight or drained weight; (3) Complete records concerning all (2) Arrangement of pieces in the con- aspects of the development or deter- tainer; mination of a process schedule, includ- (3) Container orientation during ther- ing any associated incubation tests, mal processing; shall be made available by the estab- (4) Product formulation; lishment to the Program employee (5) Particle size; upon request. (6) Maximum thickness for flexible, (c) Submittal of process information. (1) and to some extent semirigid con- Prior to the processing of canned prod- tainers during thermal processing; uct for distribution in commerce, the (7) Maximum pH; establishment shall provide the inspec- (8) Percent salt; tor at the establishment with a list of (9) Ingoing (or formulated) nitrite the process schedules (including alter- level (ppm); nate schedules) along with any addi- (10) Maximum water activity; and tional applicable information, such as (11) Product consistency or viscosity.

278 Food Safety and Inspection Service, USDA § 318.305

(b) Continuous rotary and batch agi- tial temperature specified in the proc- tating retorts. (1) Minimum headspace; ess schedule. and (d) Timing devices. Devices used to (2) Retort reel speed. time applicable thermal processing op- (c) Hydrostatic retorts. (1) Chain or eration functions or events, such as conveyor speed. process schedule time, come-up time (d) Steam/air retorts. (1) Steam/air and retort venting, shall be accurate to ratio; and assure that all such functions or events (2) Heating medium flow rate. are achieved. Pocket watches and wrist watches are not considered acceptable § 318.304 Operations in the thermal timing devices. Analog and digital processing area. clocks are considered acceptable. If (a) Posting of processes. Process sched- such clocks do not display seconds, all ules (or operating process schedules) required timed functions or events for daily production, including min- shall have at least a 1-minute safety imum initial temperatures and oper- factor over the specified thermal proc- ating procedures for thermal proc- essing operation times. Temperature/ essing equipment, shall be posted in a time recording devices shall correspond conspicuous place near the thermal within 15 minutes to the time of the processing equipment. Alternatively, day recorded on written records re- such information shall be available to quired by § 318.306. the thermal processing system oper- (e) Measurement of pH. Unless other ator and the inspector. methods are approved by the Adminis- (b) Process indicators and retort traffic trator, potentiometric methods using control. A system for product traffic electronic instruments (pH meters) control shall be established to prevent shall be used for making pH determina- product from bypassing the thermal tions when a maximum pH value is processing operation. Each basket, specified as a critical factor in a proc- crate or similar vehicle containing un- ess schedule. processed product, or at least one visi- ble container in each vehicle, shall be (Approved by Office of Management and plainly and conspicuously marked with Budget under control number 0583–0015) a heat sensitive indicator that will vis- ually indicate whether such unit has § 318.305 Equipment and procedures for heat processing systems. been thermally processed. Exposed heat sensitive indicators attached to (a) Instruments and controls common to container vehicles shall be removed be- different thermal processing systems—(1) fore such vehicles are refilled with un- Indicating temperature devices. Each re- processed product. Container loading tort shall be equipped with at least one systems for crateless retorts shall be indicating temperature device that designed to prevent unprocessed prod- measures the actual temperature with- uct from bypassing the thermal proc- in the retort. The indicating tempera- essing operation. ture device, not the temperature/time (c) Initial temperature. The initial recording device, shall be used as the temperature of the contents of the reference instrument for indicating the coldest container to be processed shall process temperature. be determined and recorded by the es- (i) Mercury-in-glass thermometers. A tablishment at the time the processing mercury-in-glass thermometer shall cycle begins to assure that the tem- have divisions that are readable to 1F perature of the contents of every con- °(or 0.5C°) and whose scale contains not tainer to be processed is not lower than more than 17F°/inch (or 4.0C°/cm) of the minimum initial temperature spec- graduated scale. Each mercury-in-glass ified in the process schedule. Thermal thermometer shall be tested for accu- processing systems which subject the racy against a known accurate stand- filled and sealed containers to water at ard upon installation and at least once any time before process timing begins a year to ensure its accuracy. Records shall be operated to assure that such that specify the date, standard used, water will not lower the temperature test method, and the person or testing of the product below the minimum ini- authority performing the test shall be

279 § 318.305 9 CFR Ch. III (1–1–14 Edition) maintained on file by the establish- time and process temperature have ment and made available to Program been met. The frequency of recording employees. A mercury-in-glass ther- should not exceed 1-minute intervals. mometer that has a divided mercury (ii) Other devices. Temperature/time column or that cannot be adjusted to recording devices or procedures used in the standard shall be repaired and test- lieu of chart-type devices must meet ed for accuracy before further use, or known accurate standards for such de- replaced. vices or procedures when tested for ac- (ii) Other devices. Temperature-indi- curacy. Such a device must be accurate cating devices, such as resistance tem- enough for ensuring that process time perature detectors, used in lieu of mer- and temperature parameters have been cury-in-glass thermometers, shall meet met. known, accurate standards for such de- (3) Steam controllers. Each retort shall vices when tested for accuracy. The be equipped with an automatic steam records of such testing shall be avail- controller to maintain the retort tem- able to FSIS program employees. perature. This may be a recording/con- (2) Temperature/time recording devices. trolling instrument when combined Each thermal processing system shall with a temperature/time recording de- be equipped with at least one tempera- vice. ture/time recording device to provide a (4) Air valves. All air lines connected permanent record of temperatures to retorts designed for pressure proc- within the thermal processing system. essing in steam shall be equipped with This recording device may be combined a globe valve or other equivalent-type with the steam controller and may be a valve or piping arrangement that will recording/controlling instrument. prevent leakage of air into the retort When compared to the known accurate during the process cycle. indicating temperature device, the re- cording accuracy shall be equal to or (5) Water valves. All retort water lines better than 1F °(or 0.5C°) at the process that are intended to be closed during a temperature. The temperature record- process cycle shall be equipped with a ing chart should be adjusted to agree globe valve or other equivalent-type with, but shall never be higher than, valve or piping arrangement that will the known accurate indicating tem- prevent leakage of water into the re- perature device. A means of preventing tort during the process cycle. unauthorized changes in the adjust- (b) Pressure processing in steam—(1) ment shall be provided. For example, a Batch still retorts. (i) The basic require- lock or a notice from management ments and recommendations for indi- posted at or near the recording device cating temperature devices and tem- warning that only authorized persons perature/time recording devices are de- are permitted to make adjustments, scribed in paragraphs (a) (1) and (2) of are satisfactory means for preventing this section. Additionally, bulb sheaths unauthorized changes. Air-operated or probes of indicating temperature de- temperature controllers shall have ade- vices and probes of temperature/time quate filter systems to ensure a supply recording devices shall be installed ei- of clean, dry air. The recorder timing ther within the retort shell or in exter- mechanism shall be accurate. nal wells attached to the retort. Exter- (i) Chart-type devices. Devices using nal wells shall be connected to the re- charts shall be used only with the cor- tort through at least a 3⁄4 inch (1.9 cm) rect chart. Each chart shall have a diameter opening and equipped with a working scale of not more than 55F°/ 1⁄16 inch (1.6 mm) or larger bleeder inch (or 12C°/cm) within a range of 20F opening so located as to provide a con- °(or 11C°) of the process temperature. stant flow of steam past the length of Chart graduations shall not exceed 2F the bulb or probe. The bleeder for ex- degrees (or 1C degree) within a range of ternal wells shall emit steam continu- 10F degrees (or 5C degrees) of the proc- ously during the entire thermal proc- ess temperature. Multipoint plotting essing period. chart-type devices shall print tempera- (ii) Steam controllers are required as ture readings at intervals that will as- described under paragraph (a)(3) of this sure that the parameters of the process section.

280 Food Safety and Inspection Service, USDA § 318.305

(iii) Steam inlet. The steam inlet to above the level of the lowest container, each retort shall be large enough to a bleeder shall be installed in the bot- provide steam for proper operation of tom of the retort to remove conden- the retort, and shall enter at a point to sate. The condensate bleeder shall be facilitate air removal during venting. so arranged that the retort operator (iv) Crate supports. Vertical still re- can observe that it is functioning prop- torts with bottom steam entry shall erly. The condensate bleeder shall be employ bottom retort crate supports. checked with sufficient frequency to Baffle plates shall not be used in the ensure adequate removal of conden- bottom of retorts. sate. Visual checks should be per- (v) Steam spreader. Perforated steam formed at intervals of not more than 15 spreaders, if used, shall be maintained minutes and the results recorded. to ensure they are not blocked or oth- Intermittent condensate removal sys- erwise inoperative. Horizontal still re- tems shall be equipped with an auto- torts shall be equipped with perforated matic alarm system that will serve as steam spreaders that extend the full a continuous monitor of condensate length of the retort unless the ade- bleeder functioning. The automatic quacy of another arrangement is docu- alarm system shall be tested at the be- mented by heat distribution data or ginning of each shift for proper func- other documentation from a processing tioning and the results recorded. If the authority. Such information shall be alarm system is not functioning prop- maintained on file by the establish- erly, it must be repaired before the re- ment and made available to Program tort is used. employees for review. (vii) Stacking equipment—(a) Equip- (vi) Bleeders and condensate removal. ment for holding or stacking containers in Bleeders, except those for external retorts. Crates, trays, gondolas, carts, wells of temperature devices, shall and other vehicles for holding or stack- have 1⁄8 inch (or 3 mm) or larger open- ing product containers in the retort ings and shall be wide open during the shall be so constructed to ensure steam entire process, including the come-up circulation during the venting, come- time. For horizontal still retorts, up, and process times. The bottom of bleeders shall be located within ap- each vehicle shall have perforations at proximately 1 foot (or 30 cm) of the least 1 inch (2.5 cm) in diameter on 2 outermost locations of containers at inch (or 5 cm) centers or the equivalent each end along the top of the retort. unless the adequacy of another ar- Additional bleeders shall be located rangement is documented by heat dis- not more than 8 feet (2.4 m) apart along tribution data or other documentation the top. Bleeders may be installed at from a processing authority and such positions other than those specified information is maintained on file by above, as long as the establishment has the establishment and made available heat distribution data or other docu- to Program employees for review. mentation from the manufacturer or (b) Divider plates. Whenever one or from a processing authority dem- more divider plates are used between onstrating that the bleeders accom- any two layers of containers or placed plish removal of air and circulate the on the bottom of a retort vehicle, the steam within the retort. This informa- establishment shall have on file docu- tion shall be maintained on file by the mentation that the venting procedure establishment and made available to allows the air to be removed from the Program employees for review. All retort before timing of the thermal bleeders shall be arranged in a way process is started. Such documentation that enables the retort operator to ob- shall be in the form of heat distribu- serve that they are functioning prop- tion data or documentation from a erly. Vertical retorts shall have at processing authority. This information least one bleeder opening located in shall be made available to Program the portion of the retort opposite the employees for review. steam inlet. All bleeders shall be ar- (viii) Bleeder and vent mufflers. If muf- ranged so that the retort operator can flers are used on bleeders or vent sys- observe that they are functioning prop- tems, the establishment shall have on erly. In retorts having a steam inlet file documentation that the mufflers

281 § 318.305 9 CFR Ch. III (1–1–14 Edition) do not impede the removal of air from (d) For crateless retort installations, the retort. Such documentation shall the establishment shall have heat dis- consist of either heat distribution data tribution data or other documentation or documentation from the muffler from the equipment manufacturer or manufacturer or from a processing au- from a processing authority that dem- thority. This information shall be onstrates that the venting procedure made available to Program employees used accomplishes the removal of air for review. and condensate. This information shall (ix) Vents—(a) Vents shall be located be maintained on file by the establish- in that portion of the retort opposite ment and made available to Program the steam inlet and shall be designed, employees for review. ( ) Examples of typical installations installed, and operated in such a way e and operating procedures that comply that air is removed from the retort be- with the requirements of this section fore timing of the thermal process is are as follows: started. Vents shall be controlled by a (1) Venting horizontal retorts. gate, plug cock, or other full-flow valve (i) Venting through multiple 1 inch which shall be fully opened to permit (2.5 cm) vents discharging directly to rapid removal of air from retorts dur- the atmosphere. ing the venting period. (b) Vents shall not be connected to a closed drain system without an atmos- pheric 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 Specifications (Figure 1): One, 1-inch (2.5 cm) without an atmospheric break in the vent for every 5 feet (1.5 m) of retort length, equipped with a gate, plug cock, or other line. A manifold header connecting full-flow valve and discharging to atmos- vents or manifolds from several still phere. The end vents shall not be more than retorts shall lead to the atmosphere. 21⁄2 feet (or 75 cm) from ends of retort. Vent- The manifold header shall not be con- ing method (Figure 1): Vent valves shall be trolled by a valve and shall be of a size wide open for at least 5 minutes and to at such that the cross-sectional area is at least 225 °F (or 107 °C), or at least 7 minutes least equal to the total cross-sectional and to at least 220 °F (or 104.5 °C). area of all connecting retort manifold (ii) Venting through multiple 1 inch pipes from the maximum number of re- (2.5 cm) vents discharging through a torts to be vented simultaneously. manifold to the atmosphere. (c) Some typical installations and op- erating 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 equip- ment manufacturer or processing au- Specifications (Figure 2): One, 1-inch (2.5 cm) thority. This information shall be vent for every 5 feet (1.5 m) of retort length; maintained on file by the establish- vents not over 21⁄2 feet (or 75 cm) from ends ment and made available to Program of retort; size of manifold for retorts less employees for review. than 15 feet (4.6 m) in length, 21⁄2 inches (6.4

282 Food Safety and Inspection Service, USDA § 318.305 cm), and for retorts 15 feet (4.6 m) and over Specifications (Figure 4): A 21⁄2 inch (6.4 cm) in length, 3 inches (7.6 cm). vent equipped with a 21⁄2 inch (6.4 cm) gate, Venting method (Figure 2): The manifold plug cock, or other full-flow valve and lo- vent gate, plug cock, or other full-flow valve cated within 2 feet (61 cm) of the center of shall be wide open for at least 6 minutes and the retort. to at least 225 °F (or 107 °C) or for at least 8 Venting method (Figure 4): The vent valve minutes and to at least 220 °F (or 104.5 °C). shall be wide open for at least 4 minutes and to at least 220 °F (or 104.5 °C). (iii) Venting through water spreaders. (2) Venting vertical retorts. (i) Venting through a 11⁄2 inch (3.8 cm) overflow.

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, 21⁄2 inches (6.4 cm). Size of water spreader (Figure 3): For retorts less than 15 feet (4.6 m) in length, 11⁄2 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-sec- tional 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 21⁄2 inch (6.4 cm) top vent for retorts not exceed- ing 15 feet (4.6 m) in length. FIGURE 5 Specifications (Figure 5): A 11⁄2 inch (3.8 cm) overflow pipe equipped with a 11⁄2 inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 11⁄2 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.

283 § 318.305 9 CFR Ch. III (1–1–14 Edition)

Specifications (Figure 6 or 7): A 1 inch (2.5 (ii) Steam controllers are required as cm) vent in lid or top side, equipped with a described in paragraph (a)(3) of this gate, plug cock, or other full-flow valve and section. discharging directly into the atmosphere or (iii) Steam inlet. The steam inlet to to a manifold header. each retort shall be large enough to Venting method (Figure 6 or 7): The vent valve shall be wide open for at least 5 min- provide steam for proper operation of utes and to at least 230 °F (110 °C), or for at the retort and shall enter at a point(s) least 7 minutes and to at least 220 °F (or 104.5 to facilitate air removal during vent- °C). ing. (iv) Bleeders. Bleeders, except those (2) Batch agitating retorts. (i) The for external wells of temperature de- basic requirements for indicating tem- vices, shall be 1⁄8 inch (or 3 mm) or larg- perature devices and temperature/time er and shall be wide open during the recording devices are described in para- entire process including the come-up graphs (a) (1) and (2) of this section. time. Bleeders shall be located within Additionally, bulb sheaths or probes of approximately 1 foot (or 30 cm) of the indicating temperature devices and outermost location of containers, at probes of temperature/time recording each end along the top of the retort. devices shall be installed either within Additional bleeders shall be located the retort shell or in external wells at- not more than 8 feet (2.4 m) apart along tached to the retort. External wells the top. Bleeders may be installed at shall be connected to the retort positions other than those specified through at least a 3⁄4 inch (1.9 cm) di- above, as long as the establishment has ameter opening and equipped with a 1⁄16 heat distribution data or other docu- (1.6 mm) or larger bleeder opening so mentation from the manufacturer or located as to provide a constant flow of from a processing authority that the steam past the length of the bulbs or bleeders accomplish removal of air and probes. The bleeder for external wells circulate the steam within the retort. shall emit steam continuously during This information shall be maintained the entire thermal processing period. on file by the establishment and made

284 Food Safety and Inspection Service, USDA § 318.305 available to Program employees for re- that only authorized persons are per- view. All bleeders shall be arranged in mitted to make adjustments are satis- a way that enables the retort operator factory means of preventing unauthor- to observe that they are functioning ized changes. properly. (vii) Bleeder and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or doc- venting procedure shall be kept on file umentation from the muffler manufac- by the establishment and made avail- turer or from a processing authority. able to Program employees for review. This information shall be maintained At the time the steam is turned on, the on file by the establishment and made drain shall be opened to remove steam available to Program employees for re- condensate from the retort. A bleeder view. shall be installed in the bottom of the (3) Continuous rotary retorts. (i) The retort to remove condensate during re- basic requirements for indicating tem- tort operation. The condensate bleeder perature devices and temperature/time shall be so arranged that the retort op- recording devices are described in para- erator can observe that it is func- graphs (a) (1) and (2) of this section. tioning properly. The condensate Additionally, bulb sheaths or probes of bleeder shall be checked with sufficient indicating temperature devices and frequency to ensure adequate removal probes of temperature/time recording of condensate. Visual checks should be devices shall be installed either within performed at intervals of not more the retort shell or in external wells at- than 15 minutes and the results re- tached to the retort. External wells corded. Intermittent condensate re- shall be connected to the retort moval systems shall be equipped with through at least a 3⁄4 inch (1.9 cm) di- an automatic alarm system that will ameter opening and equipped with a 1⁄16 serve as a continuous monitor of con- inch (1.6 mm) or larger bleeder opening densate bleeder functioning. The auto- so located as to provide a constant flow matic alarm system shall be tested at of steam past the length of the bulbs or the beginning of each shift for proper probes. The bleeder for external wells functioning and the results recorded. If shall emit steam continuously during the alarm system is not functioning the entire thermal processing period. properly, it must be repaired before the (ii) Steam controllers are required as retort is used. described in paragraph (a)(3) of this (vi) Retort or reel speed timing. The re- section. tort or reel speed shall be checked be- (iii) Steam inlet. The steam inlet to fore process timing begins and, if need- each retort shall be large enough to ed, adjusted as specified in the process provide steam for proper operation of schedule. In addition, the rotational the retort, and shall enter at a point(s) speed shall be determined and recorded to facilitate air removal during vent- at least once during process timing of ing. each retort load processed. Alter- (iv) Bleeders. Bleeders, except those natively, a recording tachometer can for external wells of temperature de- be used to provide a continuous record vices, shall be 1⁄8 inch (3.2 mm) or larg- of the speed. The accuracy of the re- er and shall be wide open during the cording tachometer shall be deter- entire process, including the come-up mined and recorded at least once per time. B!eeders shall be located within shift by checking the retort or reel approximately 1 foot (or 30 cm) of the speed using an accurate stopwatch. A outermost location of containers at means of preventing unauthorized each end along the top of the retort. speed changes on retorts shall be pro- Additional bleeders shall be located vided. For example, a lock or a notice not more than 8 feet (2.4 m) apart along from management posted at or near the top of the retort. Bleeders may be the speed adjustment device warning installed at positions other than those

285 § 318.305 9 CFR Ch. III (1–1–14 Edition) specified above, as long as the estab- used, the speed shall be manually lishment has heat distribution data or checked against an accurate stopwatch other documentation from the manu- at least once per shift and the results facturer or a processing authority that recorded. A means of preventing unau- the bleeders accomplish removal of air thorized speed changes on retorts shall and circulate the steam within the re- be provided. For example, a lock or a tort. This information shall be main- notice from management posted at or tained on file by the establishment and near the speed adjustment device warn- made available to Program employees ing that only authorized persons are for review. All bleeders shall be ar- permitted to make adjustments are ranged so that the retort operator can satisfactory means of preventing unau- observe that they are functioning prop- thorized changes. erly. (vii) Bleeders and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who deve!oped the of either heat distribution data or venting procedure shall be kept on file other documentation from the muffler by the establishment and made avail- manufacturer or from a processing au- able to Program employees for review. thority. This information shall be At the time the steam is turned on, the maintained on file by the establish- drain shall be opened to remove steam ment and made available to Program condensate from the retort. A bleeder employees for review. shall be installed in the bottom of the (4) Hydrostatic retorts. (i) The basic re- shell to remove condensate during the quirements for indicating temperature retort operation. The condensate bleed- devices and temperature/time record- er shall be so arranged that the retort ing devices are described in paragraphs operator can observe that it is func- (a) (1) and (2) of this section. Addition- tioning properly. The condensate ally, indicating temperature devices bleeder shall be checked with sufficient shall be located in the steam dome frequency to ensure adequate removal of condensate. Visual checks should be near the steam/water interface. Where performed at intervals of not more the process schedule specifies mainte- than 15 minutes and the results re- nance of particular water temperatures corded. Intermittent condensate re- in the hydrostatic water legs, at least moval systems shall be equipped with one indicating temperature device an automatic alarm system that will shall be located in each hydrostatic serve as a continuous monitor of con- water leg so that it can accurately densate bleeder functioning. The auto- measure water temperature and be eas- matic alarm system shall be tested at ily read. The temperature/time re- the beginning of each shift for proper corder probe shall be installed either functioning and the results recorded. If within the steam dome or in a well at- the alarm system is not functioning tached to the dome. Each probe shall properly, it must be repaired before the have a 1⁄16 inch (1.6 mm) or larger bleed- retort is used. er opening which emits steam continu- (vi) Retort speed timing. The rota- ously during the processing period. Ad- tional speed of the retort shall be spec- ditional temperature/time recorder ified in the process schedule. The speed probes shall be installed in the hydro- shall be adjusted as specified, and re- static water legs if the process sched- corded by the establishment when the ule specifies maintenance of particular retort is started, and checked and re- temperatures in these water legs. corded at intervals not to exceed 4 (ii) Steam controllers are required as hours to ensure that the correct retort described in paragraph (a)(3) of this speed is maintained. Alternatively, a section. recording tachometer may be used to (iii) Steam inlet. The steam inlets provide a continuous record of the shall be large enough to provide steam speed. If a recording tachometer is for proper operation of the retort.

286 Food Safety and Inspection Service, USDA § 318.305

(iv) Bleeders. Bleeder openings 1⁄4 inch ments for indicating temperature de- (or 6 mm) or larger shall be located in vices and temperature/time recording the steam chamber(s) opposite the devices are described in paragraphs point of steam entry. Bleeders shall be (a)(1) and (2) of this section. Addition- wide open and shall emit steam con- ally, bulbs or probes of indicating tem- tinuously during the entire process, in- perature devices shall be located in cluding the come-up time. All bleeders such a position that they are beneath shall be arranged in such a way that the surface of the water throughout the operator can observe that they are the process. On horizontal retorts, the functioning properly. indicating temperature device bulb or (v) Venting. Before the start of proc- probe shall be inserted directly into essing operations, the retort steam the retort shell. In both vertical and chamber(s) shall be vented to ensure horizontal retorts, the indicating tem- removal of air. Heat distribution data perature device bulb or probe shall ex- or other documentation from the man- tend directly into the water a min- ufacturer or from a processing author- imum of 2 inches (or 5 cm) without a ity demonstrating that the air is re- separable well or sleeve. In vertical re- moved from the retort prior to proc- torts equipped with a recorder/con- essing shall be kept on file at the es- troller, the controller probe shall be lo- tablishment and made available to cated at the bottom of the retort below Program employees for review. the lowest crate rest in such a position (vi) Conveyor speed. The conveyor that the steam does not strike it di- speed shall be calculated to obtain the rectly. In horizontal retorts so required process time and recorded by equipped, the controller probe shall be the establishment when the retort is located between the water surface and started. The speed shall be checked and the horizontal plane passing through recorded at intervals not to exceed 4 the center of the retort so that there is hours to ensure that the correct con- no opportunity for direct steam im- veyor speed is maintained. A recording pingement on the controller probe. Air- device may be used to provide a contin- operated temperature controllers shall uous record of the conveyor speed. have filter systems to ensure a supply When a recording device is used, the of clean, dry air. speed shall be manually checked (ii) Pressure recording device. Each re- against an accurate stopwatch at least tort shall be equipped with a pressure once per shift by the establishment. A recording device which may be com- means of preventing unauthorized bined with a pressure controller. speed changes of the conveyor shall be (iii) Steam controllers are required as provided. For example, a lock or a no- described in paragraph (a)(3) of this tice from management posted at or section. near the speed adjustment device warn- (iv) Heat distribution. Heat distribu- ing that only authorized persons are tion data or other documentation from permitted to make adjustments are the equipment manufacturer or a proc- satisfactory means of preventing unau- essing authority demonstrating uni- thorized changes. form heat distribution within the re- (vii) Bleeders and vent mufflers. If muf- tort shall be kept on file at the estab- flers are used on bleeders or vent sys- lishment and made available to Pro- tems, the establishment shall have doc- gram employees for review. umentation that the muffler do not im- (v) Crate supports. A bottom crate pede the removal of air from the retort. support shall be used in vertical re- Such documentation shall consist of ei- torts. Baffle plates shall not be used in ther heat distribution data or other the bottom of the retort. documentation from the muffler manu- (vi) Stacking equipment. For filled facturer or from a processing author- flexible containers and, where applica- ity. This information shall be main- ble, semirigid containers, stacking tained on file by the establishment and equipment shall be designed to ensure made available to Program employees that the thickness of the filled con- for review. tainers does not exceed that specified (c) Pressure processing in water—(1) in the process schedule and that the Batch still retorts. (i) The basic require- containers do not become displaced and 287 § 318.305 9 CFR Ch. III (1–1–14 Edition) overlap or rest on one another during (x) Water recirculation. When a water the thermal process. recirculation system is used for heat (vii) Drain valve. A nonclogging, distribution, the water shall be drawn water-tight drain valve shall be used. from the bottom of the retort through Screens shall be installed over all drain a suction manifold and discharged openings. through a spreader that extends the (viii) Water level. There shall be a length or circumference of the top of means of determining the water level the retort. The holes in the water in the retort during operation (i.e., by spreader shall be uniformly distrib- using a gauge, electronic sensor, or uted. The suction outlets shall be pro- sight glass indicator). For retorts re- tected with screens to keep debris from quiring complete immersion of con- entering the recirculation system. The tainers, water shall cover the top layer pump shall be equipped with a pilot of containers during the entire come- light or a similar device to warn the operator when it is not running, and up time and thermal processing periods with a bleeder to remove air when and should cover the top layer of con- starting operations. Alternatively, a tainers during cooling. For retorts flow-meter alarm system can be used using cascading water or water sprays, to ensure proper water circulation. The the water level shall be maintained adequacy of water circulation for within the range specified by the retort maintaining uniform heat distribution manufacturer or processing authority within the retort shall be documented during the entire come-up, thermal by heat distribution or other docu- processing, and cooling periods. A mentation from a processing authority means to ensure that water circulation and such data shall be maintained on continues as specified throughout the file by the establishment and made come-up, thermal processing, and cool- available to Program employees for re- ing periods shall be provided. The re- view. Alternative methods for recir- tort operator shall check and record culation of water in the retort may be the water level at intervals to ensure it used, provided there is documentation meets the specified processing param- in the form of heat distribution data or eters. other documentation from a processing (ix) Air supply and controls. In both authority maintained on file by the es- horizontal and vertical still retorts, a tablishment and made available to means shall be provided for introducing Program employees for review. compressed air or steam at the pres- (xi) Cooling water entry. In retorts for sure required to maintain container in- processing product packed in glass jars, tegrity. Compressed air and steam the incoming cooling water should not entry shall be controlled by an auto- directly strike the jars, in order to matic pressure control unit. A non- minimize glass breakage by thermal return valve shall be provided in the shock. air supply line to prevent water from (2) Batch agitating retorts. (i) The entering the system. Overriding air or basic requirements and recommenda- steam pressure shall be maintained tions for indicating temperature de- continuously during the come-up, ther- vices and temperature/time recording mal processing, and cooling periods. If devices are described in paragraphs (a) air is used to promote circulation, it (1) and (2) of this section. Additionally, shall be introduced into the steam line the indicating temperature device bulb at a point between the retort and the or probe shall extend directly into the steam control valve at the bottom of water without a separable well or the retort. The adequacy of the air cir- sleeve. The recorder/controller probe culation for maintaining uniform heat shall be located between the water sur- distribution within the retort shall be face and the horizontal plane passing documented by heat distribution data through the center of the retort so that or other documentation from a proc- there is no opportunity for steam to di- essing authority, and such data shall rectly strike the controller bulb or be maintained on file by the establish- probe. ment and made available to Program (ii) Pressure recording device. Each re- employees for review. tort shall be equipped with a pressure

288 Food Safety and Inspection Service, USDA § 318.305 recording device which may be com- tribution data or other documentation bined with a pressure controller. from a processing authority, and such (iii) Steam controllers are required data shall be maintained on file by the as described in paragraph (a)(3) of this establishment and made available to section. Program employees for review. (iv) Heat distribution. Heat distribu- (ix) Retort or reel speed timing. The re- tion data or other documentation from tort or reel speed timing shall be the equipment manufacturer or a proc- checked before process timing begins essing authority shall be kept on file and, if needed, adjusted as specified in by the establishment and made avail- the process schedule. In addition, the able to Program employees for review. rotational speed shall be determined (v) Stacking equipment. All devices and recorded at least once during proc- used for holding product containers ess timing of each retort load proc- (e.g., crates, trays, divider plates) shall essed. Alternatively, a recording ta- be so constructed to allow the water to chometer can be used to provide a con- circulate around the containers during tinuous record of the speed. The accu- the come-up and thermal process peri- racy of the recording tachometer shall ods. be determined and recorded at least (vi) Drain valve. A nonclogging, once per shift by the establishment by water-tight drain valve shall be used. checking the retort or reel speed using Screens shall be installed over all drain an accurate stopwatch. A means of pre- openings. venting unauthorized speed changes on (vii) Water level. There shall be a retorts shall be provided. For example, means of determining the water level a lock or a notice from management in the retort during operation (i.e., by posted at or near the speed adjustment using a gauge, electronic sensor, or device warning that only authorized sight glass indicator). Water shall com- persons are permitted to make adjust- pletely cover all containers during the ments are satisfactory means of pre- entire come-up, thermal processing, venting unauthorized changes. and cooling periods. A means to ensure (x) Water recirculation. If a water re- that water circulation continues as circulation system is used for heat dis- specified throughout the come-up, tribution, it shall be installed in such a thermal processing, and cooling periods manner that water will be drawn from shall be provided. The retort operator the bottom of the retort through a suc- shall check and record the adequacy of tion manifold and discharged through a the water level with sufficient fre- spreader which extends the length of quency to ensure it meets the specified the top of the retort. The holes in the processing parameters. water spreader shall be uniformly dis- (viii) Air supply and controls. Retorts tributed. The suction outlets shall be shall be provided with a means for in- protected with screens to keep debris troducing compressed air or steam at from entering the recirculation sys- the pressure required to maintain con- tem. The pump shall be equipped with tainer integrity. Compressed air and a pilot light or a similar device to warn steam entry shall be controlled by an the operator when it is not running and automatic pressure control unit. A with a bleeder to remove air when nonreturn valve shall be provided in starting operations. Alternatively, a the air supply line to prevent water flow-meter alarm system can be used from entering the system. Overriding to ensure proper water circulation. The air or steam pressure shall be main- adequacy of water circulation for tained continuously during the come- maintaining uniform heat distribution up, thermal processing, and cooling pe- within the retort shall be documented riods. If air is used to promote circula- by heat distribution data or other doc- tion, it shall be introduced into the umentation from a processing author- steam line at a point between the re- ity, and such data shall be maintained tort and the steam control valve at the on file by the establishment and made bottom of the retort. The adequacy of available to Program employees for re- the air circulation for maintaining uni- view. Alternative methods for recir- form heat distribution within the re- culation of water in the retort may be tort shall be documented by heat dis- used provided there is documentation

289 § 318.305 9 CFR Ch. III (1–1–14 Edition) in the form of heat distribution data or ments described in paragraph (a)(2) of other documentation from a processing this section. authority maintained on file by the es- (2) Heat distribution. Each atmos- tablishment and made available to pheric cooker shall be equipped and op- Program employees for review. erated to ensure uniform heat distribu- (xi) Cooling water entry. In retorts for tion throughout the processing system processing product packed in glass jars, during the thermal process. Heat dis- the incoming cooling water should not tribution data or other documentation directly strike the jars, in order to from the manufacturer or a processing minimize glass breakage by thermal authority demonstrating uniform heat shock. distribution within the cooker shall be (d) Pressure processing with steam/air kept on file by the establishment and mixtures in batch retorts. (1) The basic made available to Program employees requirements for indicating tempera- for review. ture devices and temperature/time re- (f) Other systems. All other systems cording devices are described in para- not specifically delineated in this sec- graphs (a) (1) and (2) of this section. tion and used for the thermal proc- Additionally, bulb sheaths or probes essing of canned product shall be ade- for indicating temperature devices and quate to produce shelf-stable products temperature/time recording devices or consistently and uniformly. controller probes shall be inserted di- (g) Equipment maintenance. (1) Upon rectly into the retort shell in such a installation, all instrumentation and position that steam does not strike controls shall be checked by the estab- them directly. lishment for proper functioning and ac- curacy and, thereafter, at any time (2) Steam controllers are required as their functioning or accuracy is sus- described in paragraph (a)(3) of this pect. section. (2) At least once a year each thermal (3) Recording pressure controller. A re- processing system shall be examined by cording pressure controller shall be an individual not directly involved in used to control the air inlet and the daily operations to ensure the proper steam/air mixture outlet. functioning of the system as well as all (4) Circulation of steam/air mixtures. A auxiliary equipment and instrumenta- means shall be provided for the circula- tion. In addition, each thermal proc- tion of the steam/air mixture to pre- essing system should be examined be- vent formation of low-temperature fore the resumption of operation fol- pockets. The efficiency of the circula- lowing an extended shutdown. tion system shall be documented by (3) Air and water valves that are in- heat distribution data or other docu- tended to be closed during thermal mentation from a processing authority, processing shall be checked by the es- and such data shall be maintained on tablishment for leaks. Defective valves file by the establishment and made shall be repaired or replaced as needed. available to Program employees for re- (4) Vent and bleeder mufflers shall be view. The circulation system shall be checked and maintained or replaced by checked to ensure its proper func- the establishment to prevent any re- tioning and shall be equipped with a duction in vent or bleeder efficiency. pilot light or a similar device to warn (5) When water spreaders are used for the operator when it is not func- venting, a maintenance schedule shall tioning. Because of the variety of exist- be developed and implemented to as- ing designs, reference shall be made to sure that the holes are maintained at the equipment manufacturer for de- their original size. tails of installation, operation, and (6) Records shall be kept on all main- control. tenance items that could affect the (e) Atmospheric cookers—(1) Tempera- adequacy of the thermal process. ture/time recording device. Each atmos- Records shall include the date and type pheric cooker (e.g., hot water bath) of maintenance performed and the per- shall be equipped with at least one son conducting the maintenance. temperature/time recording device in (h) Container cooling and cooling accordance with the basic require- water. (1) Potable water shall be used 290 Food Safety and Inspection Service, USDA § 318.306 for cooling except as provided for in no buildup of microorganisms on sur- paragraphs (h) (2) and (3) of this sec- faces in contact with the containers. tion. (Approved by the Office of Management and (2) Cooling canal water shall be Budget under control number 0583–0015) chlorinated or treated with a chemical approved by the Administrator as hav- [51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000] ing a bactericidal effect equivalent to chlorination. There shall be a measur- § 318.306 Processing and production able residual of the sanitizer in the records. water at the discharge point of the At least the following processing and canal. Cooling canals shall be cleaned production information shall be re- and replenished with potable water to corded by the establishment: date of prevent the buildup of organic matter production; product name and style; and other materials. container code; container size and (3) Container cooling waters that are type; and the process schedule, includ- recycled or reused shall be handled in ing the minimum initial temperature. systems that are so designed, operated, Measurements made to satisfy the re- and maintained so there is no buildup quirements of § 318.303 regarding the of microorganisms, organic matter, control of critical factors shall be re- and other materials in the systems and corded. In addition, where applicable, in the waters. System equipment, such the following information and data as pipelines, holding tanks and cooling shall also be recorded: towers, shall be constructed and in- (a) Processing in steam—(1) Batch still stalled so that they can be cleaned and retorts. For each retort batch, record inspected. In addition, the establish- the retort number or other designa- ment shall maintain, and make avail- tion, the approximate number of con- able to Program employees for review, tainers or the number of retort crates information on at least the following: per retort load, product initial tem- (i) System design and construction; perature, time steam on, the time and (ii) System operation including the temperature vent closed, the start of rates of renewal with fresh, potable process timing, time steam off, and the water and the means for treating the actual processing time. The indicating water so that there is a measurable re- temperature device and the tempera- sidual of an acceptable sanitizer, per ture recorder shall be read at the same paragraph (h)(2) of this section, in the time at least once during process tim- water at the point where the water ing and the observed temperatures re- exits the container cooling vessel; corded. (iii) System maintenance including (2) Batch agitating retorts. In addition procedures for the periodic cleaning to recording the information required and sanitizing of the entire system; for batch, still steam retorts in para- and graph (a)(1) of this section, record the (iv) Water quality standards, such as functioning of the condensate bleed- microbiological, chemical and phys- er(s) and the retort or reel speed. ical, monitoring procedures including (3) Continuous rotary retorts. Record the frequency and site(s) of sampling, the retort system number, the approxi- and the corrective actions taken when mate total number of containers re- water quality standards are not met. torted, product initial temperature, (i) Post-process handling of containers time steam on, the time and tempera- Containers shall be handled in a man- ture vent closed, time process tempera- ner that will prevent damage to the ture reached, the time the first can en- hermetic seal area. All worn and frayed ters and the time the last can exits the belting, can retarders, cushions, and retort. The retort or reel speed shall be the like shall be replaced with non- determined and recorded at intervals porous materials. To minimize con- not to exceed 4 hours. Readings of the tainer abrasions, particularly in the indicating temperature device(s) and seal area, containers should not remain temperature recorder(s) shall be made stationary on moving conveyors. All and recorded at the time the first con- post-process container handling equip- tainer enters the retort and thereafter ment should be kept clean so there is with sufficient frequency to ensure

291 § 318.307 9 CFR Ch. III (1–1–14 Edition) compliance with the process schedule. in paragraph (b)(1) of this section, These observations should be made and record the retort or reel speed. recorded at intervals not exceeding 30 (c) Processing in steam/air mixtures. minutes of continuous retort oper- For each retort batch, record the re- ation. Functioning of the condensate tort number or other designation, the bleeder(s) shall be observed and re- approximate number of containers or corded at the time the first container number of retort crates per retort load, enters the retort and thereafter as product initial temperature, time specified in § 318.305(b)(3)(v). steam on, venting procedure, if appli- (4) Hydrostatic retorts. Record the re- cable, the start of process timing, tort system number, the approximate maintenance of circulation of the steam/air mixture, air flow rate or total number of containers retorted, forced recirculation flow rate (if crit- product initial temperature, time ical), overriding pressure maintained, steam on, the time and temperature time steam off, and actual processing vent(s) closed, time process tempera- time. The indicating temperature de- ture reached, time first containers vice and the temperature recorder shall enter the retort, time last containers be read at the same time at least once exit the retort, and, if specified in the during process timing and the observed process schedule, measurements of temperatures recorded. temperatures in the hydrostatic water (d) Atmospheric cookers—(1) Batch-type legs. Readings of the temperature indi- systems. For each cooker batch, record cating device, which is located in the the cooker number or other designa- steam/water interface, and the tem- tion and the approximate number of perature recording device shall be ob- containers. In addition, record all crit- served and the temperatures recorded ical factors of the process schedule at the time the first containers enter such as cooker temperature, initial the steam dome. Thereafter, these in- temperature, the time the thermal struments shall be read and the tem- process cycle begins and ends, hold peratures recorded with sufficient fre- time, and the final internal product quency to ensure compliance with the temperature. temperature specified in the process (2) Continuous-type systems. Record schedule and should be made at least the cooker number or other designa- every hour of continuous retort oper- tion, the time the first containers ation. Container conveyor speed, and enter and the last containers exit a for agitating hydrostatic retorts, the cooker, and the approximate total rotative chain speed, shall be deter- number of containers processed. In ad- mined and recorded at intervals of suf- dition, record all critical factors of the ficient frequency to ensure compliance process schedule such as the initial with the process schedule and should temperature, cooker speed, and final be performed at least every 4 hours. internal product temperature. (b) —(1) Processing in water Batch still (Approved by the Office of Management and retorts. For each retort batch, record Budget under control number 0583–0015) the retort number or other designa- tion, the approximate number of con- § 318.307 Record review and mainte- tainers or number of retort crates per nance. retort load, product initial tempera- (a) Process records. Charts from tem- ture, time steam on, the start of proc- perature/time recording devices shall ess timing, water level, water recir- be identified by production date, con- culation rate (if critical), overriding tainer code, processing vessel number pressure maintained, time steam off, or other designation, and other data as and actual processing time. The indi- necessary to enable correlation with cating temperature device and the the records required in § 318.306. Each temperature recorder shall be read at entry on a record shall be made at the the same time at least once during time the specific event occurs, and the process timing and the observed tem- recording individual shall sign or ini- peratures recorded. tial each record form. No later than 1 (2) Batch agitating retorts. In addition working day after the actual process, to recording the information required the establishment shall review all

292 Food Safety and Inspection Service, USDA § 318.308 processing and production records to § 318.308 Deviations in processing. ensure completeness and to determine (a) Whenever the actual process is if all product received the process less than the process schedule or when schedule. All records, including the any critical factor does not comply temperature/time recorder charts and with the requirements for that factor critical factor control records, shall be as specified in the process schedule, it signed or initialed and dated by the shall be considered a deviation in proc- person conducting the review. All proc- essing. essing and production records required (b) Deviations in processing (or proc- in this subpart shall be made available ess deviations) must be handled accord- to Program employees for review. ing to: (b) Automated process monitoring and (1)(i) A HACCP plan for canned prod- recordkeeping. Automated process mon- uct that addresses hazards associated itoring and recordkeeping systems with microbial contamination, or, shall be designed and operated in a (ii) Alternative documented proce- manner that will ensure compliance dures that will ensure that only safe with the applicable requirements of and stable product is shipped in com- § 318.306. merce; or (c) Container closure records. Written (iii) Paragraph (d) of this section. records of all container closure exami- (c) [Reserved] nations shall specify the container (d) Procedures for handling process code, the date and time of container deviations where the HACCP plan for thermally processed/commercially closure examination, the measure- sterile product does not address food ment(s) obtained, and any corrective safety hazards associated with micro- actions taken. Records shall be signed bial contamination, where there is no or initialed by the container closure approved total quality control system, technician and shall be reviewed and or where the establishment has no al- signed by the establishment within 1 ternative documented procedures for working day after the actual produc- handling process deviations. tion to ensure that the records are (1) Deviations identified in-process. If a complete and that the closing oper- deviation is noted at any time before ations have been properly controlled. the completion of the intended process All container closure examination schedule, the establishment shall: records required in this subpart shall (i) Immediately reprocess the prod- be made available to Program employ- uct using the full process schedule; or ees for review. (ii) Use an appropriate alternate (d) Distribution of product. Records process schedule provided such a proc- shall be maintained by the establish- ess schedule has been established in ac- ment identifying initial distribution of cordance with § 318.302 (a) and (b) and is the finished product to facilitate, if filed with the inspector in accordance necessary, the segregation of specific with § 318.302(c); or production lots that may have been (iii) Hold the product involved and contaminated or are otherwise unsound have the deviation evaluated by a proc- for their intended use. essing authority to assess the safety (e) Retention of records. Copies of all and stability of the product. Upon com- processing and production records re- pletion of the evaluation, the establish- quired in § 318.306 shall be retained for ment shall provide the inspector the no less than 1 year at the establish- following: ment, and for an additional 2 years at (a) A complete description of the de- the establishment or other location viation along with all necessary sup- from which the records can be made porting documentation; available to Program employees within (b) A copy of the evaluation report; 3 working days. and (c) A description of any product dis- (Approved by the Office of Management and position actions, either taken or pro- Budget under control number 0583–0015) posed. [51 FR 45619, Dec. 19, 1986, as amended at 65 (iv) Product handled in accordance FR 34389, May 30, 2000] with paragraph (d)(1)(iii) of this section

293 § 318.308 9 CFR Ch. III (1–1–14 Edition) shall not be shipped from the establish- § 318.302(b)) shall be used before con- ment until the Program has reviewed tainer entry to the retort is restarted; all of the information submitted and or (iii) container entry to the retort approved the product disposition ac- shall be prevented and the reel re- tions. started to empty the retort. The dis- (v) If an alternate process schedule is charged containers shall be reproc- used that is not on file with the inspec- essed, repacked and reprocessed, or de- tor or if an alternate process schedule stroyed. Product to be destroyed shall is immediately calculated and used, be handled as ‘‘U.S. Inspected and Con- the product shall be set aside for fur- demned’’, as defined in § 318.2(ee) of this ther evaluation in accordance with subchapter, and disposed of in accord- paragraphs (d)(1)(iii) and (iv) of this ance with part 314 of this subchapter. section. ° (vi) When a deviation occurs in a con- (2) For temperature drops of 10 F (or ° tinuous rotary retort, the product shall 5.5 C) or more, all containers in the re- be handled in accordance with para- tort shall be given an emergency still graphs (d)(1)(iii) and (iv) of this section process (developed per § 318.302(b)). The or in accordance with the following time the reel was stopped and the time procedures: the retort was used for a still retort (a) Emergency stops. process shall be marked on the tem- (1) When retort jams or breakdowns perature/time recording device by the occur during the processing operations, establishment and entered on the other all containers shall be given an emer- production records required in § 318.306. gency still process (developed per Alternatively, container entry to the § 318.302(b)) before the retort is cooled retort shall be prevented and the reel or the retort shall be cooled promptly restarted to empty the retort. The dis- and all containers removed and either charged containers shall be either re- reprocessed, repacked and reprocessed, processed, repacked and reprocessed, or or destroyed. Regardless of the proce- destroyed. Product to be destroyed dure used, containers in the retort in- shall be handled as ‘‘U.S. Inspected and take valve and in transfer valves be- Condemned’’, as defined in § 301.2(ee) of tween retort shells at the time of a jam this subchapter, and disposed of in ac- or breakdown shall be removed and ei- cordance with part 314 of this sub- ther reprocessed, repacked and reproc- chapter. essed and or destroyed. Product to be (2) destroyed shall be handled as ‘‘U.S. In- Deviations identified through record spected and Condemned’’, as defined in review. Whenever a deviation is noted § 301.2(ttt) of this subchapter, and dis- during review of the processing and posed of in accordance with part 314 of production records required by § 318.307 this subchapter. (a) and (b), the establishment shall (2) The time the retort reel stopped hold the product involved and the devi- and the time the retort is used for an ation shall be handled in accordance emergency still retort process shall be with paragraphs (d)(1) (iii) and (iv) of noted on the temperature/time record- this section. ing device and entered on the other (e) Process deviation file. The estab- production records required in § 318.306. lishment shall maintain full records re- (b) Temperature drops. When the re- garding the handling of each deviation. tort temperature drops below the tem- Such records shall include, at a min- perature specified in the process sched- imum, the appropriate processing and ule, the reel shall be stopped and the production records, a full description of following actions shall be taken: the corrective actions taken, the eval- (1) For temperature drops of less uation procedures and results, and the ° ° than 10 F (or 5.5 C) either, (i) all con- disposition of the affected product. tainers in the retort shall be given an Such records shall be maintained in a emergency still process (developed per separate file or in a log that contains § 318.302(b)) before the reel is restarted; the appropriate information. The file (ii) container entry to the retort shall or log shall be retained in accordance be prevented and an emergency agi- tating process (developed per with § 318.307(e) and shall be made

294 Food Safety and Inspection Service, USDA § 318.309 available to Program employees upon nated, the temperature lowered to request. within the required range, and new sample containers incubated for the re- (Approved by the Office of Management and Budget under control number 0583–0015) quired time. (iii) Product requiring incubation. [51 FR 45619, Dec. 19, 1986, as amended at 53 Shelf stable product requiring incuba- FR 49848, Dec. 12, 1988; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532, tion includes: Sept. 5, 2000] (a) Low acid products as defined in § 318.300(m); and § 318.309 Finished product inspection. (b) Acidified low acid products as de- (a) Finished product inspections fined in § 318.300(b). must be handled according to: (iv) Incubation samples. (a) From each (1) A HACCP plan for canned product load of product processed in a batch- that addresses hazards associated with type thermal processing system (still microbiological contamination; or agitation), the establishment shall (2) An FSIS-approved total quality select at least one container for incu- control system; bation. (3) Alternative documented proce- (b) For continuous rotary retorts, hy- dures that will ensure that only safe drostatic retorts, or other continuous- and stable product is shipped in com- type thermal processing systems, the merce; or establishment shall select at least one (4) Paragraph (d) of this section. container per 1,000 for incubation. (b)–(c) [Reserved] (c) Only normal-appearing containers (d) Procedures for handling finished shall be selected for incubation. product inspections where the HACCP (v) Incubation time. Canned product plan for thermally processed/commer- requiring incubation shall be incubated cially sterile product does not address for not less than 10 days (240 hours) food safety hazards associated with mi- under the conditions specified in para- crobial contamination, where there is graph (d)(1)(ii) of this section. no approved total quality control sys- (vi) Incubation checks and record main- tem, or where the establishment has no tenance. Designated establishment em- alternative documented procedures for ployees shall visually check all con- handling process deviations. tainers under incubation each working (1) Incubation of shelf stable canned day and the inspector shall be notified product—(i) Incubator. The establish- when abnormal containers are de- ment shall provide incubation facilities tected. All abnormal containers should which include an accurate tempera- be allowed to cool before a final deci- ture/time recording device, an indi- sion on their condition is made. For cating temperature device, a means for each incubation test the establishment the circulation of the air inside the in- shall record at least the product name, cubator to prevent temperature vari- container size, container code, number ations, and a means to prevent unau- of containers incubated, in and out thorized entry into the facility. The dates, and incubation results. The es- Program is responsible for the security tablishment shall retain such records, of the incubator. along with copies of the temperature/ (ii) Incubation temperature. The incu- time recording charts, in accordance bation temperature shall be main- with § 318.307(e). tained at 95±5 °F (35±2.8 °C). If the incu- (vii) Abnormal containers. The finding bation temperature falls below 90 °F (or of abnormal containers (as defined in 32 °C) or exceeds 100 °F (or 38 °C) but § 318.300(a)) among incubation samples does not reach 103 °F (or 39.5 °C), the is cause to officially retain at least the incubation temperature shall be ad- code lot involved. justed within the required range and (viii) Shipping. No product shall be the incubation time extended for the shipped from the establishment before time the sample containers were held the end of the required incubation pe- at the deviant temperature. If the incu- riod except as provided in this para- bation temperature is at or above 103 graph or paragraph (b) or (c) of this °F (or 39.5 °C) for more than 2 hours, section. An establishment wishing to the incubation test(s) shall be termi- ship product prior to the completion of

295 § 318.310 9 CFR Ch. III (1–1–14 Edition) the required incubation period shall this subpart. Upon request, the recall submit a written proposal to the area procedure shall be made available to supervisor. Such a proposal shall in- Program employees for review. clude provisions that will assure that (Approved by the Office of Management and shipped product will not reach the re- Budget under control number 0583–0015) tail level of distribution before sample incubation is completed and that prod- uct can be returned promptly to the es- PART 319—DEFINITIONS AND tablishment should such action be STANDARDS OF IDENTITY OR deemed necessary by the incubation COMPOSITION test results. Upon receipt of written approval from the area supervisor, Subpart A—General product may be routinely shipped pro- Sec. vided the establishment continues to 319.1 Labeling and preparation of standard- comply with all requirements of this ized products. subpart. 319.2 Products and nitrates and nitrites. (2) Container condition—(i) Normal 319.5 Mechanically Separated (Species). containers. Only normal-appearing con- 319.6 Limitations with respect to use of Me- chanically Separated (Species). tainers shall be shipped from an estab- 319.10 Requirements for substitute stand- lishment as determined by an appro- ardized meat food products named by use priate sampling plan or other means of an expressed nutrient content claim acceptable to Program employees. and a standardized term. (ii) Abnormal containers. When abnor- mal containers are detected by any Subpart B—Raw Meat Products means other than incubation, the es- 319.15 Miscellaneous beef products. tablishment shall inform the inspector, 319.29 Miscellaneous pork products. and the affected code lot(s) shall not be shipped until the Program has deter- Subpart C—Cooked Meats mined that the product is safe and sta- 319.80 Barbecued meats. ble. Such a determination will take 319.81 Roast beef parboiled and steam roast- into account the cause and level of ed. abnormals in the affected lot(s) as well as any product disposition actions ei- Subpart D—Cured Meats, Unsmoked and ther taken or proposed by the estab- Smoked lishment. 319.100 Corned beef. (Approved by the Office of Management and 319.101 Corned beef brisket. Budget under control number 0583–0015) 319.102 Corned beef round and other corned beef cuts. [51 FR 45619, Dec. 19, 1986, as amended at 57 319.103 Cured beef tongue. FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, 319.104 Cured pork products. 1992; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, 319.105 ‘‘Ham patties,’’ ‘‘Chopped ham,’’ May 30, 2000; 65 FR 53532, Sept. 5, 2000] ‘‘Pressed ham,’’ ‘‘Spiced ham,’’ and simi- lar products. § 318.310 Personnel and training. 319.106 ‘‘Country Ham,’’ ‘‘Country Style All operators of thermal processing Ham,’’ ‘‘Dry Cured Ham,’’ ‘‘Country Pork systems specified in § 318.305 and con- Shoulder,’’ ‘‘Country Style Pork Shoul- tainer closure technicians shall be der,’’ and ‘‘Dry Cured Pork Shoulder.’’ under the direct supervision of a person 319.107 Bacon. who has successfully completed a Subpart E—Sausage Generally: Fresh school of instruction that is generally Sausage recognized as adequate for properly training supervisors of canning oper- 319.140 Sausage. ations. 319.141 Fresh pork sausage. 319.142 Fresh beef sausage. [51 FR 45619, Dec. 19, 1986] 319.143 Breakfast sausage. 319.144 Whole hog sausage. § 318.311 Recall procedure. 319.145 Italian sausage products. Establishments shall prepare and Subpart F—Uncooked, Smoked Sausage maintain a current procedure for the recall of all canned product covered by 319.160 Smoked pork sausage.

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