{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 113 sorted by section_id", "rows": [["21:21:2.0.1.1.13.1.1.1", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "A", "Subpart A\u2014General Provisions", "", "\u00a7 113.3 Definitions.", "FDA", "", "", "", "For the purposes of this part, the following definitions apply:\n\n(a)  Aseptic processing and packaging  means the filling of a commercially sterilized cooled product into presterilized containers, followed by aseptic hermetical sealing, with a presterilized closure, in an atmosphere free of microorganisms.\n\n(b)  Bleeders  means openings used to remove air that enters with steam from retorts and steam chambers and to promote circulation of steam in such retorts and steam chambers. Bleeders may serve as a means of removing condensate.\n\n(c)  Come-up-time  means the time which elapses between the introduction of steam into the closed retort and the time when the retort reaches the required processing temperature.\n\n(d)  Commercial processor  includes any person engaged in commercial, custom, or institutional (church, school, penal, or other organization) processing of food, including pet food. Persons engaged in the production of foods that are to be used in market or consumer tests are also included.\n\n(e)  Commercial sterility:  (1) \u201cCommercial sterility\u201d of thermally processed food means the condition achieved\u2014\n\n(i) By the application of heat which renders the food free of\u2014\n\n( a ) Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and\n\n( b ) Viable microorganisms (including spores) of public health significance; or\n\n(ii) By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.\n\n(2) \u201cCommercial sterility\u201d of equipment and containers used for aseptic processing and packaging of food means the condition achieved by application of heat, chemical sterilant(s), or other appropriate treatment that renders the equipment and containers free of viable microorganisms having public health significance, as well as microorganisms of nonhealth significance, capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.\n\n(f)  Critical factor  means any property, characteristic, condition, aspect, or other parameter, variation of which may affect the scheduled process and the attainment of commercial sterility.\n\n(g)  Flame sterilizer  means an apparatus in which hermetically sealed containers are agitated at atmospheric pressure, by either continuous, discontinuous, or reciprocating movement, with impinging gas flames to achieve sterilization temperatures. A holding period in a heated section may follow the initial heating period.\n\n(h)  Headspace, gross  is 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 (the top of the double seam of a can or the top edge of a glass jar).\n\n(i)  Headspace, net  of a container is the vertical distance between the level of the product (generally the liquid surface) in the upright rigid container and the inside surface of the lid.\n\n(j)  Hermetically sealed container  means a container that is designed and intended to be secure against the entry of microorganisms and thereby to maintain the commercial sterility of its contents after processing.\n\n(k)  Incubation  means the holding of a sample(s) at a specified temperature for a specified period of time for the purpose of permitting or stimulating the growth of microorganisms.\n\n(l)  Initial temperature  means the average temperature of the contents of the coldest container to be processed at the time the thermal processing cycle begins, as determined after thorough stirring or shaking of the filled and sealed container.\n\n(m)  Lot  means that amount of a product produced during a period of time indicated by a specific code.\n\n(n)  Low-acid foods  means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (a w ) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods.\n\n(o)  Minimum thermal process  means the application of heat to food, either before or after sealing in a hermetically sealed container, for a period of time and at a temperature scientifically determined to be adequate to ensure destruction of microorganisms of public health significance.\n\n(p)  Operating process  means the process selected by the processor that equals or exceeds the minimum requirements set forth in the scheduled process.\n\n(q)  Retort  means any closed vessel or other equipment used for the thermal processing of foods.\n\n(r)  Scheduled process  means the process selected by the processor as adequate under the conditions of manufacture for a given product to achieve commercial sterility. This process may be in excess of that necessary to ensure destruction of microorganisms of public health significance, and shall be at least equivalent to the process established by a competent processing authority to achieve commercial sterility.\n\n(s)  Shall  is used to state mandatory requirements.\n\n(t)  Should  is used to state recommended or advisory procedures or to identify recommended equipment.\n\n(u)  Vacuum-packed products  means those products that are sealed in a container under the vacuum specified in the scheduled process, the maintenance of which vacuum is critical to the adequacy of the scheduled process.\n\n(v)  Vents  means openings through the retort shell, controlled by gate, plug cock, or other adequate valves used for the elimination of air during the venting period.\n\n(w)  Water activity  (a w ) is a measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature."], ["21:21:2.0.1.1.13.1.1.2", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "A", "Subpart A\u2014General Provisions", "", "\u00a7 113.5 Current good manufacturing practice.", "FDA", "", "", "", "The criteria in \u00a7\u00a7 113.10, 113.40, 113.60, 113.81, 113.83, 113.87, 113.89, and 113.100 shall apply in determining whether the facilities, methods, practices, and controls used by the commercial processor in the manufacture, processing, or packing of low-acid foods in hermetically sealed containers are operated or administered in a manner adequate to protect the public health."], ["21:21:2.0.1.1.13.1.1.3", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "A", "Subpart A\u2014General Provisions", "", "\u00a7 113.10 Personnel.", "FDA", "", "", "", "The operators of processing systems, retorts, aseptic processing and packaging systems and product formulating systems (including systems wherein water activity is used in conjunction with thermal processing) and container closure inspectors shall be under the operating supervision of a person who has attended a school approved by the Commissioner for giving instruction appropriate to the preservation technology involved and who has been identified by that school as having satisfactorily completed the prescribed course of instruction. This person shall supervise only in those areas for which a school approved by the Commissioner identifies the person as having satisfactorily completed training."], ["21:21:2.0.1.1.13.3.1.1", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "C", "Subpart C\u2014Equipment", "", "\u00a7 113.40 Equipment and procedures.", "FDA", "", "", "[76 FR 11906, Mar. 3, 2011; 76 FR 81363, Dec. 28, 2011]", "(a)  Equipment and procedures for pressure processing in steam in still retorts \u2014(1)  Temperature-indicating device.  Each retort shall be equipped with at least one temperature-indicating device that accurately indicates the temperature during processing. Each temperature-indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is maintained by the processor shall have a tag, seal, or other means of identity.\n\n(i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions.\n\n(ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n(iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced.\n\n(iv) A temperature-indicating device shall be accurate to 1 \u00b0F (0.5 \u00b0C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 \u00b0F per inch (4 \u00b0C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective.\n\n(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a \n 3/4 -inch (2 centimeters) diameter opening and equipped with a \n 1/16 -inch (1.5 millimeters) or larger bleeder opening so located as to provide a full flow of steam past the length of the temperature-indicating device sensor. The bleeders for external wells shall emit steam continuously during the entire processing period. The temperature-indicating device\u2014not the temperature recording device\u2014shall be the reference instrument for indicating the processing temperature.\n\n(2)  Temperature-recording device.  Each retort shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart. The temperature-recording device sensor shall be installed either within the retort shell or in a well attached to the shell. Each temperature-recording device sensor well shall have a \n 1/16 -inch (1.5 millimeters) or larger bleeder that emits steam continuously during the processing period.\n\n(i)  Analog or graphical recordings.  Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 \u00b0F per inch (12 \u00b0C per centimeter) within a range of 20 \u00b0F (10 \u00b0C) of the process temperature. Chart graduations shall not exceed 2 \u00b0F (1 \u00b0C) within a range of 10 \u00b0F (5 \u00b0C) of the process temperature. Temperature-recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(ii)  Digital recordings.  Temperature-recording devices, such as data loggers, that record numbers or create other digital records may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(iii)  Adjustments.  The temperature-recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(iv)  Temperature controller.  The temperature-recording device may be combined with the steam controller and may be a recorder-controller.\n\n(3)  Pressure gages.  Each retort should be equipped with a pressure gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or less.\n\n(4)  Steam controller.  Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recorder-controller when combined with a temperature-recording device. The steam controller may be air-operated and actuated by a temperature sensor positioned near the temperature-indicating device in the retort. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air. A steam controller activated by the steam pressure of the retort is acceptable if it is carefully maintained mechanically so that it operates satisfactorily.\n\n(5)  Steam inlet.  The steam inlet to each still retort shall be large enough to provide sufficient steam for proper operation of the retort. Steam may enter either the top portion or the bottom portion of the retort but, in any case, shall enter the portion of the retort opposite the vent; for example, steam inlet in bottom portion and vent in top portion.\n\n(6)  Crate supports.  A bottom crate support shall be used in vertical still retorts. Baffle plates shall not be used in the bottom of still retorts.\n\n(7)  Steam spreaders.  Steam spreaders are continuations of the steam inlet line inside the retort. Horizontal still retorts shall be equipped with steam spreaders that extend the length of the retort. For steam spreaders along the bottom of the retort, the perforations should be along the top 90\u00b0 of the pipe, that is, within 45\u00b0 on either side of the top center. Horizontal still retorts over 30 feet (9.1 meters) long should have two steam inlets connected to the spreader. In vertical still retorts, the steam spreaders, if used, should be perforated along the center line of the pipe facing the interior of the retort or along the sides of the pipe. The number of perforations should be such that the total cross-sectional area of the perforations is equal to 1.5 to 2 times the cross-sectional area of the smallest restriction in the steam inlet line.\n\n(8)  Bleeders.  Bleeders, except those for temperature-indicating device wells, shall be 1/8-inch (3 millimeters) or larger 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 (30.5 centimeters) 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 meters) apart along the top. Bleeders may be installed at positions other than those specified in this paragraph, as long as there is evidence in the form of heat distribution data that they accomplish adequate removal of air and circulation of steam within the retort. Vertical retorts shall have at least one bleeder opening located in that portion of the retort opposite the steam inlet. In retorts having top steam inlet and bottom venting, a bleeder shall be installed in the bottom of the retort to remove condensate. All bleeders shall be arranged so that the operator can observe that they are functioning properly.\n\n(9)  Stacking equipment and position of containers.  Crates, trays, gondolas,  etc.,  for holding containers shall be made of strap iron, adequately perforated sheet metal, or other suitable material. When perforated sheet metal is used for the bottoms, the perforations should be approximately the equivalent of 1-inch (2.5 centimeters) holes on 2-inch (5.1 centimeters) centers. If dividers are used between the layers of containers, they should be perforated as stated in this paragraph. The positioning of containers in the retort, when specified in the scheduled process, shall be in accordance with that process.\n\n(10)  Air valves.  Retorts using air for pressure cooling shall be equipped with a suitable valve to prevent air leakage into the retort during processing.\n\n(11)  Water valves.  Retorts using water for cooling shall be equipped with a suitable valve to prevent leakage of water into the retort during processing.\n\n(12)  Vents.  Vents shall be installed in such a way that air is removed from the retort before timing of the process is started. Vents shall be controlled by gate, plug cock, or other adequate type valves which shall be fully open to permit rapid discharge of air from the retort during the venting period. Vents shall not be connected directly to a closed drain system. If the overflow is used as a vent, there shall be an atmospheric break in the line before it connects to a closed drain. The vent shall be located in that portion of the retort opposite the steam inlet; for example, steam inlet in bottom portion and vent in top portion. Where a retort manifold connects several vent pipes from a single still retort, it shall be controlled by a gate, plug cock, or other adequate type of valve. The retort manifold shall be of a size that the cross-sectional area of the pipe is larger than the total cross-sectional area of all connecting vents. The discharge shall not be directly 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 that the cross-sectional area is at least equal to the total cross-sectional area of all connecting retort manifold pipes from all retorts venting simultaneously. Timing of the process shall not begin until the retort has been properly vented and the processing temperature has been reached. Some typical installations and operating procedures reflecting the requirements of this section for venting still retorts without divider plates are given in paragraphs (a)(12)(i)(A) through (a)(12)(i)(D) and (a)(12)(ii)(A) and (a)(12)(ii)(B) of this section.\n\n(i)  Venting horizontal retorts.  (A) Venting through multiple 1-inch (2.5 centimeters) vents discharging directly to atmosphere.\n\n( 1 )  Specifications.  One 1-inch (2.5 centimeters) vent for every 5 feet (1.5 meters) of retort length equipped with a gate or plug cock valve and discharging to atmosphere; end vents not more than 2.5 feet (76 centimeters) from ends of retort.\n\n( 2 )  Venting method.  Vent valves should be wide open for at least 5 minutes and to at least 225 \u00b0F (107 \u00b0C), or at least 7 minutes and to at least 220 \u00b0F (104.5 \u00b0C).\n\n(B) Venting through multiple 1-inch (2.5 centimeters) vents discharging through a manifold to atmosphere.\n\n( 1 )  Specifications.  One 1-inch (2.5 centimeters) vent for every 5 feet (1.5 meters) of retort length; and vents not over 2.5 feet (76 centimeters) from ends of retort. Size of manifold\u2014for retorts less than 15 feet (4.6 meters) in length, 2.5 inches (6.4 centimeters); for retorts 15 feet (4.6 meters) and over in length, 3 inches (7.6 centimeters).\n\n( 2 )  Venting method.  Manifold vent gate or plug cock valve should be wide open for at least 6 minutes and to at least 225 \u00b0F (107 \u00b0C), or for at least 8 minutes and to at least 220 \u00b0F (104.5 \u00b0C).\n\n(C) Venting through water spreaders.\n\n( 1 )  Size of vent and vent valve.  For retorts less than 15 feet (4.6 meters) in length, 2 inches (5.1 centimeters); for retorts 15 feet (4.6 meters) and over in length, 2.5 inches (6.4 centimeters).\n\n( 2 )  Size of water spreader.  For retorts less than 15 feet (4.6 meters) in length, 1.5 inches (3.8 centimeters); for retorts 15 feet (4.6 meters) and over in length, 2 inches (5.1 centimeters). The number of holes should be such that their total cross-sectional area is approximately equal to the cross-sectional area of the vent pipe inlet.\n\n( 3 )  Venting method.  Water spreader vent gate or plug cock valve should be wide open for at least 5 minutes and to at least 225 \u00b0F (107 \u00b0C), or for at least 7 minutes and to at least 220 \u00b0F (104.5 \u00b0C).\n\n(D) Venting through a single 2.5-inch (6.4 centimeters) top vent (for retorts not exceeding 15 feet (4.6 meters) in length).\n\n( 1 )  Specifications.  A 2.5-inch (6.4 centimeters) vent equipped with a 2.5-inch (6.4 centimeters) gate or plug cock valve and located within 2 feet (61 centimeters) of the center of the retort.\n\n( 2 )  Venting method.  Vent gate or plug cock valve should be wide open for at least 4 minutes and to at least 220 \u00b0F (104.5 \u00b0C).\n\n(ii)  Venting vertical retorts.  (A) Venting through a 1.5-inch (3.8 centimeters) overflow.\n\n( 1 )  Specifications.  A 1.5-inch (3.8 centimeters) overflow pipe equipped with a 1.5-inch (3.8 centimeters) gate or plug cock valve and with not more than 6 feet (1.8 meters) of 1.5-inch (3.8 centimeters) pipe beyond the valve before break to the atmosphere or to a manifold header.\n\n( 2 )  Venting method.  Vent gate or plug cock valve should be wide open for at least 4 minutes and to at least 218 \u00b0F (103.5 \u00b0C), or for at least 5 minutes and to at least 215 \u00b0F (102 \u00b0C).\n\n(B) Venting through a single 1-inch (2.5 centimeters) side or top vent.\n\n( 1 )  Specifications.  A 1-inch (2.5 centimeters) vent in lid or top side, equipped with a 1-inch (2.5 centimeters) gate or plug cock valve and discharging directly into the atmosphere or to a manifold header.\n\n( 2 )  Venting method.  Vent gate or plug cock valve should be wide open for at least 5 minutes and to at least 230 \u00b0F (110 \u00b0C), or for at least 7 minutes and to at least 220 \u00b0F (104.5 \u00b0C).\n\n(iii)  Other procedures.  Other installations and operating procedures that deviate from the requirements in paragraph (a)(12) of this section may be used if there is evidence in the form of heat distribution data, which shall be kept on file, that they accomplish adequate venting of air.\n\n(13)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process.\n\n(i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process.\n\n(ii) Closing machine vacuum in vacuum-packed products shall be observed and recorded at intervals of sufficient frequency to ensure that the vacuum is as specified in the scheduled process.\n\n(iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes.\n\n(iv) When the product style results in stratification or layering of the primary product in the containers, the positioning of containers in the retort shall be according to the scheduled process.\n\n(b)  Equipment and procedures for pressure processing in water in still retorts \u2014(1)  Temperature-indicating device.  Each retort shall be equipped with at least one temperature-indicating device that accurately indicates the temperature during processing. Each temperature-indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is maintained by the processor shall have a tag, seal, or other means of identity.\n\n(i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions.\n\n(ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n(iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced.\n\n(iv) A temperature-indicating device shall be accurate to 1 \u00b0F (0.5 \u00b0C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 \u00b0F per inch (4 \u00b0C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective.\n\n(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. In both horizontal and vertical retorts, the temperature-indicating device sensor shall be inserted directly into the retort shell or in a separate well or sleeve attached to the retort. The temperature-indicating device sensor shall be located so that it is beneath the surface of the water throughout the process and where there is adequate circulation to ensure accurate temperature measurement. On horizontal retorts, the temperature-indicating device sensor should be located in the side at the center of the retort. The temperature-indicating device\u2014not the temperature-recording device\u2014shall be the reference instrument for indicating the processing temperature.\n\n(2)  Temperature-recording device.  Each retort shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart.\n\n(i)  Analog or graphical recordings.  Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 \u00b0F per inch (12 \u00b0C per centimeter) within a range of 20 \u00b0F (10 \u00b0C) of the process temperature. Chart graduations shall not exceed 2 \u00b0F (1 \u00b0C) within a range of 10 \u00b0F (5 \u00b0C) of the process temperature. Temperature-recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(ii)  Digital recordings.  Temperature-recording devices, such as data loggers, that record numbers or create other digital records may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(iii)  Adjustments.  The temperature-recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(iv)  Temperature controller.  The temperature-recording device may be combined with the steam controller and may be a combination recorder-controller. For a vertical retort equipped with a combination recorder-controller, the temperature recorder-controller sensor 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. For a horizontal retort equipped with a combination recorder-controller, the temperature recorder-controller sensor 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 sensor. For all still retort systems that pressure process in water and are equipped with combination recorder-controllers, the temperature recorder-controller sensors shall be located where the recorded temperature is an accurate measurement of the scheduled process temperature and is not affected by the heating media.\n\n(3)  Pressure gages.  (i) Each retort should be equipped with a pressure gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or less.\n\n(ii) Each retort should have an adjustable pressure relief or control valve of a capacity sufficient to prevent an undesired increase in retort pressure when the water valve is wide open and should be installed in the overflow line.\n\n(4)  Steam controller.  Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. The steam controller may be combined with a temperature-recording device and, thus, may be a combination recorder-controller. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.\n\n(5)  Steam introduction.  Steam shall be distributed in the bottom of the retort in a manner adequate to provide uniform heat distribution throughout the retort. In vertical retorts, uniform steam distribution can be achieved by any of several methods. In horizontal retorts, the steam distributor shall run the length of the bottom of the retort with perforations distributed uniformly along the upper part of the pipe.\n\n(6)  Crate supports.  A bottom crate support shall be used in vertical still retorts. Baffle plates shall not be used in the bottom of the retort. Centering guides should be installed so as to ensure that there is about a 1.5-inch (3.8 centimeters) clearance between the side wall of the crate and the retort wall.\n\n(7)  Stacking equipment and position of containers.  Crates, trays, gondolas,  etc.,  for holding containers shall be made of strap iron, adequately perforated sheet metal, or other suitable material. When perforated sheet metal is used for the bottoms, the perforations should be approximately the equivalent of 1-inch (2.5 centimeters) holes on 2-inch (5.1 centimeters) centers. If divider plates are used between the layers of containers, they should be perforated as stated in this paragraph. The positioning of containers in the retort, when specified in the scheduled process, shall be in accordance with that process. Dividers, racks, trays, or other means of positioning of flexible containers shall be designed and employed to ensure even circulation of heating medium around all containers in the retort.\n\n(8)  Drain valve.  A nonclogging, water-tight valve shall be used. A screen shall be installed or other suitable means shall be used on all drain openings to prevent clogging.\n\n(9)  Air supply and controls.  In both horizontal and vertical still retorts for pressure processing in water, a means shall be provided for introducing compressed air at the proper pressure and rate. The proper pressure shall be controlled by an automatic pressure control unit. A check valve shall be provided in the air supply line to prevent water from entering the system. Air or water circulation shall be maintained continuously during the come-up time and during processing and cooling periods. The adequacy of the air or water circulation for uniform heat distribution within the retort shall be established in accordance with procedures recognized by a competent processing authority and records shall be kept on file. 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.\n\n(10)  Water level indicator.  There shall be a means of determining the water level in the retort during operation, e.g., by using a sensor, gage, water glass, or petcock(s). Water shall cover the top layer of containers during the entire come-up time and processing periods and should cover the top layer of containers during the cooling periods. The operator shall check and record the water level at intervals sufficient to ensure its adequacy.\n\n(11)  Water circulation.  When a water circulating 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 and should have an aggregate area not greater than the cross-sectional area of the outlet line from the pump. The suction outlets shall be protected with nonclogging screens or other suitable means shall be used to keep debris from entering the circulating system. The pump shall be designed to provide proper flow on startup and during operation, such as with a bleeder or other suitable means to remove air during startup and with an appropriate device or design to prevent pump cavitation during operation. The pump shall be equipped with a signaling device to warn the operator when it is not running. Alternative methods for circulation of water in the retort may be used when established by a competent authority as adequate for even heat distribution.\n\n(12)  Cooling water supply.  In vertical retorts, the cooling water should be introduced at the top of the retort between the water and container levels. In horizontal retorts the cooling water should be introduced into the suction side of the pump. A check valve should be included in the cooling water line.\n\n(13)  Retort headspace.  The headspace necessary to control the air pressure should be maintained between the water level and the top of the retort shell.\n\n(14)  Vertical and horizontal still retorts.  Vertical and horizontal still retorts should follow the arrangements in the diagrams in this paragraph. Other installation and operating procedures that deviate from these arrangements may be used, as long as there is evidence in the form of heat distribution data or other suitable information, which shall be kept on file, which demonstrates that the heat distribution is adequate.\n\nA\u2014Water line.\n \n B\u2014Steam line.\n \n C\u2014Temperature control.\n \n D\u2014Overflow line.\n \n E 1 \u2014Drain line.\n \n E 2 \u2014Screens.\n \n F\u2014Check valves.\n \n G\u2014Line from hot water storage.\n \n H\u2014Suction line and manifold.\n \n I\u2014Circulating pump.\n \n J\u2014Petcocks.\n \n K\u2014Recirculating line.\n \n L\u2014Steam distributor.\n \n M\u2014Temperature-controller sensor.\n \n N\u2014Temperature-indicating device sensor.\n \n O\u2014Water spreader.\n \n P\u2014Safety valve.\n \n Q\u2014Vent valve for steam processing.\n \n R\u2014Pressure gage.\n \n S\u2014Inlet air control.\n \n T\u2014Pressure control.\n \n U\u2014Air line.\n \n V\u2014To pressure control instrument.\n \n W\u2014To temperature control instrument.\n \n X\u2014Wing nuts.\n \n Y 1 \u2014Crate support.\n \n Y 2 \u2014Crate guides.\n \n Z\u2014Constant flow orifice valve.\n \n Z 1 \u2014Constant flow orifice valve used during come-up.\n \n Z 2 \u2014Constant flow orifice valve used during cook.\n\nA\u2014Water line.\n\nB\u2014Steam line.\n\nC\u2014Temperature control.\n\nD\u2014Overflow line.\n\nE 1 \u2014Drain line.\n\nE 2 \u2014Screens.\n\nF\u2014Check valves.\n\nG\u2014Line from hot water storage.\n\nH\u2014Suction line and manifold.\n\nI\u2014Circulating pump.\n\nJ\u2014Petcocks.\n\nK\u2014Recirculating line.\n\nL\u2014Steam distributor.\n\nM\u2014Temperature-controller sensor.\n\nN\u2014Temperature-indicating device sensor.\n\nO\u2014Water spreader.\n\nP\u2014Safety valve.\n\nQ\u2014Vent valve for steam processing.\n\nR\u2014Pressure gage.\n\nS\u2014Inlet air control.\n\nT\u2014Pressure control.\n\nU\u2014Air line.\n\nV\u2014To pressure control instrument.\n\nW\u2014To temperature control instrument.\n\nX\u2014Wing nuts.\n\nY 1 \u2014Crate support.\n\nY 2 \u2014Crate guides.\n\nZ\u2014Constant flow orifice valve.\n\nZ 1 \u2014Constant flow orifice valve used during come-up.\n\nZ 2 \u2014Constant flow orifice valve used during cook.\n\n(15)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process.\n\n(i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process.\n\n(ii) Closing machine vacuum in vacuum-packed products shall be observed and recorded at intervals of sufficient frequency to ensure that the vacuum is as specified in the scheduled process.\n\n(iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes.\n\n(iv) When the product style results in stratification or layering of the primary product in the containers, the positioning of containers in the retort shall be according to the scheduled process.\n\n(c)  Equipment and procedures for pressure processing in steam in continuous agitating retorts \u2014(1)  Temperature-indicating device.  Each retort shall be equipped with at least one temperature-indicating device that accurately indicates the temperature during processing. Each temperature-indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is maintained by the processor shall have a tag, seal, or other means of identity.\n\n(i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions.\n\n(ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n(iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced.\n\n(iv) A temperature-indicating device shall be accurate to 1 \u00b0F (0.5 \u00b0C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 \u00b0F per inch (4 \u00b0C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective.\n\n(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a \n 3/4 -inch (2 centimeters) diameter opening and equipped with a \n 1/16 -inch (1.5 millimeters) or larger bleeder opening so located as to provide a full flow of steam past the length of the temperature-indicating device sensor. The bleeders for external wells shall emit steam continuously during the entire processing period. The temperature-indicating device\u2014not the temperature-recording device\u2014shall be the reference instrument for indicating the processing temperature.\n\n(2)  Temperature-recording device.  Each retort shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart. The temperature-recording device sensor shall be installed either within the retort shell or in a well attached to the shell. Each temperature-recording device sensor well shall have a \n 1/16 -inch (1.5 millimeters) or larger bleeder that emits steam continuously during the processing period.\n\n(i)  Analog or graphical recordings.  Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 \u00b0F per inch (12 \u00b0C per centimeter) within a range of 20 \u00b0F (10 \u00b0C) of the process temperature. Chart graduations shall not exceed 2 \u00b0F (1 \u00b0C) within a range of 10 \u00b0F (5 \u00b0C) of the process temperature. Temperature-recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(ii)  Digital recordings.  Temperature-recording devices, such as data loggers, that record numbers or create other digital records may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(iii)  Adjustments.  The temperature-recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(iv)  Temperature controller.  The temperature-recording device may be combined with the steam controller and may be a recorder-controller.\n\n(3)  Pressure gages.  Each retort should be equipped with a pressure gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or less.\n\n(4)  Steam controller.  Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recorder-controller when combined with a temperature-recording device. A steam controller activated by the steam pressure of the retort is acceptable if it is carefully maintained mechanically so that it operates satisfactorily. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.\n\n(5)  Bleeders.  Bleeders, except those for temperature-indicating device wells, shall be \n 1/8 -inch (3 millimeters) or larger and shall be wide open during the entire process, including the come-up time. Bleeders shall be located within approximately 1 foot (30.5 centimeters) 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 meters) apart along the top of the retort. All bleeders shall be arranged so that the operator can observe that they are functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate or shall be equipped with an automatic alarm system(s) that would serve as a continuous monitor of condensate-bleeder functioning. Visual checks should be done at intervals of not more than 15 minutes. A record of such checks should be kept to show that the bleeder is functioning properly.\n\n(6)  Venting and condensate removal.  Vents shall be located in that portion of the retort opposite the steam inlet. Air shall be removed before processing is started. Heat distribution data or documentary proof from the manufacturer or from a competent processing authority, demonstrating that adequate venting is achieved, shall be kept on file. At the time steam is turned on, the drain should be opened for a time sufficient to remove steam condensate from the retort, and provision shall be made for continuing drainage of condensate during the retort operation. The condensate bleeder in the bottom of the shell serves as an indicator of continuous condensate removal.\n\n(7)  Retort speed timing.  The rotational speed of the retort shall be specified in the scheduled process. The speed shall be adjusted and recorded when the retort is started, at any time a speed change is made, and at intervals of sufficient frequency to ensure that the retort speed is maintained as specified in the scheduled process. These adjustments and recordings should be made every 4 hours or less. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. A means of preventing unauthorized speed changes on retorts shall be provided. A lock or a notice from management posted at or near the speed adjustment device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(8)  Emergency stops.  If a retort jams or breaks down during processing operations, necessitating cooling the retort for repairs, the retort shall be operated in such a way that ensures that the product is commercially sterile, or the retort is to be cooled promptly and all containers either reprocessed, repacked and reprocessed, or discarded. When operated as a still retort, all containers shall be given a full still retort process before the retort is cooled. If, in such an emergency, a scheduled still process or another process established to ensure commercial sterility is to be used, it shall be made readily available to the retort operator.\n\n(i) Any containers in the retort intake valve or in transfer valves between cooker shells of a continuous retort at the time of breakdown shall either be reprocessed, repacked and reprocessed, or discarded.\n\n(ii) Both the time at which the reel stopped and the time the retort was used for a still retort process, if so used, shall be indicated on the temperature-recording device record and entered on the other production records required in this chapter. If the alternative procedure of prompt cooling is followed, the subsequent handling methods used for the containers in the retort at the time of stopping and cooling shall be entered on the production records.\n\n(9)  Temperature drop.  If the temperature of the continuous retort drops below the temperature specified in the scheduled process while containers are in the retort, the retort reel shall be stopped promptly. An automatic device should be used to stop the reel when the temperature drops below the specified process temperature. Before the reel is restarted, all containers in the retort shall be given a complete scheduled still retort process if the temperature drop was 10 \u00b0F (5 \u00b0C) or more below the specified temperature, or alternatively, container entry to the retort shall be stopped and the reel restarted to empty the retort. The discharged containers shall be either reprocessed, repacked and reprocessed, or discarded. Both the time at which the reel stopped and the time the retort was used for a still retort process, if so used, shall be indicated on the temperature-recording device record and entered on the other production records required in this chapter. If the alternative procedure of emptying the retort is followed, the subsequent handling methods used for the containers in the retort at the time of the temperature drop shall be entered on the production records. If the temperature drop was less than 10 \u00b0F (5 \u00b0C), a scheduled authorized emergency still process approved by a qualified person(s) having expert knowledge of thermal processing requirements may be used before restarting the retort reel. Alternatively, container entry to the retort shall be stopped and an authorized emergency agitating process may be used before container entry to the retort is restarted. When emergency procedures are used, no containers may enter the retort and the process and procedures used shall be noted on the production records.\n\n(10)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. The minimum headspace of containers, if specified in the scheduled process, shall be measured and recorded at intervals of sufficient frequency to ensure that the headspace is as specified in the scheduled process. The headspace of solder-tipped, lapseam (vent hole) cans may be measured by net weight determinations. The headspace of double seamed cans may also be measured by net weight determinations for homogenous liquids, taking into account the specific can end profile and other factors which affect the headspace, if proof of the accuracy of such measurements is maintained and the procedure and resultant headspace is in accordance with the scheduled process. When the product consistency is specified in the scheduled process, the consistency of the product shall be determined by objective measurements on the product taken from the filler before processing and recorded at intervals of sufficient frequency to ensure that the consistency is as specified in the scheduled process. Minimum closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, minimum net weight, and percent solids shall be as specified in the scheduled process for all products when deviations from such specifications may affect the scheduled process. All measurements and recordings of critical factors should be made at intervals not to exceed 15 minutes.\n\n(d)  Equipment and procedures for pressure processing in steam in discontinuous agitating retorts \u2014(1)  Temperature-indicating device.  Each retort shall be equipped with at least one temperature-indicating device that accurately indicates the temperature during processing. Each temperature-indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is maintained by the processor shall have a tag, seal, or other means of identity.\n\n(i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions.\n\n(ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n(iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced.\n\n(iv) A temperature-indicating device shall be accurate to 1 \u00b0F (0.5 \u00b0C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 \u00b0F per inch (4 \u00b0C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective.\n\n(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a \n 3/4 -inch (2 centimeters) diameter opening and equipped with a \n 1/16 -inch (1.5 millimeters) or larger bleeder opening so located as to provide a full flow of steam past the length of the temperature-indicating device sensor. The bleeders for external wells shall emit steam continuously during the entire processing period. The temperature-indicating device\u2014not the temperature-recording device\u2014shall be the reference instrument for indicating the processing temperature.\n\n(2)  Temperature-recording device.  Each retort shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart. The temperature-recording device sensor shall be installed either within the retort shell or in a well attached to the shell. Each temperature-recording device sensor well shall have a \n 1/16 -inch (1.5 millimeters) or larger bleeder that emits steam continuously during the processing period.\n\n(i)  Analog or graphical recordings.  Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 \u00b0F per inch (12 \u00b0C per centimeter) within a range of 20 \u00b0F (10 \u00b0C) of the process temperature. Chart graduations shall not exceed 2 \u00b0F (1 \u00b0C) within a range of 10 \u00b0F (5 \u00b0C) of the process temperature. Temperature-recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(ii)  Digital recordings.  Temperature-recording devices, such as data loggers, that record numbers or create other digital records may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(iii)  Adjustments.  The temperature-recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(iv)  Temperature controller.  The temperature-recording device may be combined with the steam controller and may be a recorder-controller.\n\n(3)  Pressure gages.  Each retort should be equipped with a pressure gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or less.\n\n(4)  Steam controller.  Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recorder-controller when combined with a temperature-recording device. A steam controller activated by the steam pressure of the retort is acceptable if it is mechanically maintained so that it operates satisfactorily. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.\n\n(5)  Bleeders.  Bleeders, except those for temperature-indicating device wells, shall be \n 1/8 -inch (3 millimeters) or larger and shall be wide open during the entire process, including the come-up time. Bleeders shall be located within approximately 1 foot (30.5 centimeters) 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 meters) apart along the top. Bleeders may be installed at positions other than those specified in this paragraph, as long as there is evidence in the form of heat distribution data that they accomplish adequate removal of air and circulation of heat within the retort. In retorts having top steam inlet and bottom venting, a bleeder shall be installed in the bottom of the retort to remove condensate. All bleeders shall be arranged in a way that enables the operator to observe that they are functioning properly.\n\n(6)  Venting and condensate removal.  The air in each retort shall be removed before processing is started. Heat distribution data or documentary proof from the manufacturer or from a competent processing authority, demonstrating that adequate venting is achieved, shall be kept on file. At the time steam is turned on, the drain should be opened for a time sufficient to remove steam condensate from the retort and provision should be made for continuing drainage of condensate during the retort operation.\n\n(7)  Retort speed timing.  The rotational speed of the retort shall be specified in the scheduled process. The speed shall be adjusted, as necessary, to ensure that the speed is as specified in the scheduled process. The rotational speed as well as the process time shall be recorded for each retort load processed. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. A means of preventing unauthorized speed changes on retorts shall be provided. A lock or a notice from management posted at or near the speed-adjustment device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(8)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. The minimum headspace of containers in each retort load to be processed, if specified in the scheduled process, shall be measured and recorded at intervals of sufficient frequency to ensure that the headspace is as specified in the scheduled process. The headspace of solder-tipped, lap seam (vent hole) cans may be measured by net weight determinations. When the product consistency is specified in the scheduled process, the consistency of the product shall be determined by objective measurements on the product taken from the filler before processing and recorded at intervals of sufficient frequency to ensure that the consistency is as specified in the scheduled process. Minimum closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, minimum net weight, and percent solids shall be as specified in the scheduled process for all products for which deviations from such specifications may affect the scheduled process. All measurements and recordings of critical factors should be made at intervals not to exceed 15 minutes.\n\n(e)  Equipment and procedures for pressure processing in water in discontinuous agitating retorts \u2014(1)  Temperature-indicating device.  Each retort shall be equipped with at least one temperature-indicating device that accurately indicates the temperature during processing. Each temperature-indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is maintained by the processor shall have a tag, seal, or other means of identity.\n\n(i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions.\n\n(ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n(iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced.\n\n(iv) A temperature-indicating device shall be accurate to 1 \u00b0F (0.5 \u00b0C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 \u00b0F per inch (4 \u00b0C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective.\n\n(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. In both horizontal and vertical retorts, the temperature-indicating device sensor shall be inserted directly into the retort shell or in a separate well or sleeve attached to the retort. The temperature-indicating device sensor shall be located so that it is beneath the surface of the water throughout the process and where there is adequate circulation to ensure accurate temperature measurement. On horizontal retorts, the temperature-indicating device sensor should be located in the side at the center of the retort. The temperature-indicating device\u2014not the temperature-recording device\u2014shall be the reference instrument for indicating the processing temperature.\n\n(2)  Temperature-recording device.  Each retort shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart. The temperature-recording device sensor shall be installed either within the retort shell or in a well attached to the shell.\n\n(i)  Analog or graphical recordings.  Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 \u00b0F per inch (12 \u00b0C per centimeter) within a range of 20 \u00b0F (10 \u00b0C) of the process temperature. Chart graduations shall not exceed 2 \u00b0F (1 \u00b0C) within a range of 10 \u00b0F (5 \u00b0C) of the process temperature. Temperature-recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(ii)  Digital recordings.  Temperature-recording devices, such as data loggers, that record numbers or create other digital records may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(iii)  Adjustments.  The temperature-recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(iv)  Temperature controller.  The temperature-recording device may be combined with the steam controller and may be a recorder-controller. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.\n\n(3)  Pressure gages.  Each retort should be equipped with a pressure gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or less.\n\n(4)  Steam controller.  Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recorder-controller when combined with a temperature-recording device. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.\n\n(5)  Retort speed timing.  The rotational speed of the retort shall be specified in the scheduled process. The speed shall be adjusted, as necessary, to ensure that the speed is as specified in the scheduled process. The rotational speed as well as the process time shall be recorded for each retort load processed. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. A means of preventing unauthorized speed changes shall be provided. A lock or a notice from management posted at or near the speed adjustment device that provides a warning that only authorized persons are permitted to make adjustment is a satisfactory means of preventing unauthorized changes.\n\n(6)  Air supply and controls.  When air is used to provide overpressure:\n\n(i) A means shall be provided for introducing compressed air at the proper pressure and rate. The proper pressure shall be controlled by an automatic pressure control unit. A check valve shall be provided in the air supply line to prevent water from entering the system.\n\n(ii) A water level indicator, e.g., sensor, gage, water glass, or petcock(s), shall be used for determining the water level in the retort during operation. Water shall cover the top layer of containers during the entire come-up time and processing periods and should also cover the top layer of containers during the cooling periods. The operator shall check and record the water level at intervals sufficient to ensure its adequacy.\n\n(7)  Water circulation.  When a water circulating 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 and should have an aggregate area not greater than the cross-sectional area of the outlet line from the pump. The suction outlets shall be protected with nonclogging screens or other suitable means shall be used to keep debris from entering the circulating system. The pump shall be designed to provide proper flow on startup and during operation, such as with a bleeder or other suitable means to remove air during startup and with an appropriate device or design to prevent pump cavitation during operation. The pump shall be equipped with a signaling device to warn the operator when it is not running. Alternative methods for circulation of water in the retort may be used when established by a competent authority as adequate for even heat distribution.\n\n(8)  Drain valve.  A nonclogging, water-tight valve shall be used. A screen shall be installed or other suitable means shall be used on all drain openings to prevent clogging.\n\n(9)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. The minimum headspace of containers, if specified in the scheduled process, shall be measured and recorded at intervals of sufficient frequency to ensure that the headspace is as specified in the scheduled process. The headspace of solder-tipped, lap seam (vent hole) cans may be measured by net weight determinations. When the product consistency is specified in the scheduled process, the consistency of the product shall be determined by objective measurements on the product taken from the filler before processing and recorded at intervals of sufficient frequency to ensure that the consistency is as specified in the scheduled process. Minimum closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, minimum net weight, and percent solids shall be as specified in the scheduled process for all products when deviations from such specifications may affect the scheduled process. All measurements and recordings of critical factors should be made at intervals not to exceed 15 minutes.\n\n(f)  Equipment and procedures for pressure processing in steam in hydrostatic retorts \u2014(1)  Temperature-indicating device.  Each retort shall be equipped with at least one temperature-indicating device that accurately indicates the temperature during processing. Each temperature-indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is maintained by the processor shall have a tag, seal, or other means of identity.\n\n(i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions.\n\n(ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n(iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced.\n\n(iv) A temperature-indicating device shall be accurate to 1 \u00b0F (0.5 \u00b0C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 \u00b0F per inch (4 \u00b0C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective.\n\n(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be located in the steam dome near the steam-water interface. When the scheduled process specifies maintenance of particular temperatures in the hydrostatic water legs, a temperature-indicating device sensor shall be located in each hydrostatic water leg in a position near the bottom temperature-recording device sensor. The temperature-indicating device\u2014not the temperature-recording device\u2014shall be the reference instrument for indicating the processing temperature.\n\n(2)  Temperature-recording device.  Each retort shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart. The temperature-recording device sensor shall be installed either within the steam dome or in a well attached to the dome. Each temperature-recording device sensor well shall have a \n 1/16 -inch (1.5 millimeters) or larger bleeder that emits steam continuously during the processing period. Additional temperature-recording device sensors shall be installed in the hydrostatic water legs in situations where the scheduled process specifies maintenance of particular temperatures in the hydrostatic water legs.\n\n(i)  Analog or graphical recordings.  Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 \u00b0F per inch (12 \u00b0C per centimeter) within a range of 20 \u00b0F (10 \u00b0C) of the process temperature. Chart graduations shall not exceed 2 \u00b0F (1 \u00b0C) within a range of 10 \u00b0F (5 \u00b0C) of the process temperature. Temperature-recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(ii)  Digital recordings.  Temperature-recording devices, such as data loggers, that record numbers or create other digital recordings may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n(iii)  Adjustments.  The temperature-recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(iv)  Temperature controller.  The temperature-recording device may be combined with the steam controller and may be a recorder-controller.\n\n(3)  Pressure gages.  Each retort should be equipped with a pressure gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or less.\n\n(4)  Recording of temperatures.  Temperatures indicated by the temperature-indicating device or devices shall be entered on a suitable form during processing operations. Temperatures shall be recorded by an accurate temperature-recording device or devices at the following points:\n\n(i) In the steam chamber between the steam-water interface and the lowest container position.\n\n(ii) Near the top and the bottom of each hydrostatic water leg if the scheduled process specifies maintenance of particular temperatures in the legs.\n\n(5)  Steam controller.  Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recorder-controller when combined with a temperature-recording device. A steam controller activated by the steam pressure of the retort is acceptable if it is carefully mechanically maintained so that it operates satisfactorily. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.\n\n(6)  Venting.  Before the start of processing operations, the retort steam chamber or chambers shall be vented to ensure removal of air.\n\n(7)  Bleeders.  Bleeder openings \n 1/4 -inch (6 millimeters) or larger shall be located at the top of the steam chamber or chambers 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.\n\n(8)  Retort speed.  The speed of the container-conveyor chain shall be specified in the scheduled process and shall be determined and recorded at the start of processing and at intervals of sufficient frequency to ensure that the retort speed is maintained as specified. The speed should be determined and recorded every 4 hours. An automatic device should be used to stop the chain when the temperature drops below that specified in the scheduled process. A means of preventing unauthorized speed changes shall be provided. A lock or a notice from management posted at or near the speed-adjusting device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(9)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process.\n\n(i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process.\n\n(ii) Closing machine vacuum in vacuum-packed products shall be observed and recorded at intervals of sufficient frequency to ensure that the vacuum is as specified in the scheduled process.\n\n(iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes.\n\n(g)  Aseptic processing and packaging systems \u2014(1)  Product sterilizer \u2014(i)  Equipment \u2014(A)  Temperature-indicating device.  Each product sterilizer shall be equipped with at least one temperature-indicating device that accurately indicates the temperature during processing. Each temperature-indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is maintained by the processor shall have a tag, seal, or other means of identity.\n\n( 1 ) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions.\n\n( 2 ) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n( 3 ) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced.\n\n( 4 ) A temperature-indicating device shall be accurate to 1 \u00b0F (0.5 \u00b0C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 \u00b0F per inch (4 \u00b0C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective.\n\n( 5 ) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device\u2014not the temperature-recording device\u2014shall be the reference instrument for indicating the processing temperature.\n\n(B)  Temperature-recording device.  Each product sterilizer shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart. A temperature-recording device sensor shall be installed in the product at the holding-tube outlet between the holding tube and the inlet to the cooler. Additional temperature-recording device sensors shall be located at each point where temperature is specified as a critical factor in the scheduled process.\n\n( 1 )  Analog or graphical recordings.  Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 \u00b0F per inch (12 \u00b0C per centimeter) within a range of 20 \u00b0F (10 \u00b0C) of the desired product sterilization temperature. Chart graduations shall not exceed 2 \u00b0F (1 \u00b0C) within a range of 10 \u00b0F (5 \u00b0C) of the process temperature. Temperature-recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n( 2 )  Digital recordings.  Temperature-recording devices, such as data loggers, that record numbers or create other digital recordings may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.\n\n( 3 )  Adjustments.  The temperature-recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(C)  Temperature controller.  An accurate temperature controller shall be installed and capable of ensuring that the desired product sterilization temperature is maintained. Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.\n\n(D)  Product-to-product regenerators.  When a product-to-product regenerator is used to heat the cold unsterilized product entering the sterilizer by means of a heat exchange system, it shall be designed, operated, and controlled so that the pressure of the sterilized product in the regenerator is greater than the pressure of any unsterilized product in the regenerator to ensure that any leakage in the regenerator is from the sterilized product into the unsterilized product.\n\n(E)  Differential pressure recorder-controller.  When a product-to-product regenerator is used, it shall be equipped with an accurate differential pressure recorder-controller. The differential pressure recorder-controller shall be accurate to within 2 pounds per square inch (13.8 kilopascals). One pressure sensor shall be installed at the sterilized product regenerator outlet and the other pressure sensor shall be installed at the unsterilized product regenerator inlet. The sensor and recorder of the differential pressure recorder-controller shall be tested for accuracy against an accurate reference device upon installation and at least once every 3 months of operation thereafter, or more frequently if necessary, to ensure its accuracy.\n\n( 1 )  Analog or graphical recordings.  Differential pressure recorder-controllers that create analog or graphical recordings may be used. Differential pressure recorder-controllers that record to charts shall be used only with the appropriate chart. The scale divisions of the chart shall not exceed 2 pounds per square inch (13.8 kilopascals) on a working scale of not more than 20 pounds per square inch per inch of scale (55 kilopascals per centimeter).\n\n( 2 )  Digital recordings.  Differential pressure recorder-controllers, such as data loggers, that record numbers or create other digital recordings may be used. Such differential pressure recorder-controllers shall record the differential pressure at intervals that will assure that the minimum differential pressure is maintained.\n\n(F)  Flow control.  A flow control device shall be located upstream from the holding tube and shall be operated to maintain the required rate of product flow. A means of preventing unauthorized flow adjustments shall be provided. A lock or a notice from management posted at or near the flow controlling device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(G)  Product holding tube.  The product-sterilizing holding tube shall be designed to give continuous holding of every particle of food for at least the minimum holding time specified in the scheduled process. The holding tube shall be designed so that no portion of the tube between the product inlet and the product outlet can be heated, and it must be sloped upward at least \n 1/4 -inch per foot (2.1 centimeters per meter).\n\n(H)  Flow-diversion systems.  If a processor elects to install a flow-diversion system, it should be installed in the product piping located between the product cooler and the product filler or aseptic surge tank and should be designed to divert flow away from the filler or aseptic surge tank automatically. Controls and/or warning systems should be designed and installed with necessary sensors and actuators to operate whenever the sterilizing temperature in the holding tube or pressure differential in the product regenerator drops below specified limits. Flow-diversion systems should be designed and operated in accordance with recommendations of an aseptic processing and packaging authority.\n\n(I)  Equipment downstream from the holding tube.  Product coolers, aseptic surge tanks, or any other equipment downstream from the holding tube, with rotating or reciprocating shafts, valve stems, instrument connections, or other such points, are subject to potential entry of microorganisms into the product. Such locations in the system should be equipped with steam seals or other effective barriers at the potential access points. Appropriate means should be provided to permit the operator to monitor the performance of the seals or barriers during operations.\n\n(ii)  Operation \u2014(A)  Startup.  Before the start of aseptic processing operations the product sterilizer and all product-contact surfaces downstream shall be brought to a condition of commercial sterility.\n\n(B)  Temperature drop in product-sterilizing holding tube.  When product temperature in the holding tube drops below the temperature specified in the scheduled process, product flow should be diverted away from the filler or aseptic surge tank by means of a flow-diversion system. If for any reason product subjected to a temperature drop below the scheduled process is filled into containers, the product shall be segregated from product that received the scheduled process. The processing deviation shall be handled in accordance with \u00a7 113.89. The product holding tube and any further system portions affected shall be returned to a condition of commercial sterility before product flow is resumed to the filler or to the aseptic surge tank.\n\n(C)  Loss of proper pressures in the regenerator.  When a regenerator is used, the product may lose sterility whenever the pressure of sterilized product in the regenerator is less than 1 pound per square inch (6.9 kilopascals) greater than the pressure of unsterilized product in the regenerator. In this case, product flow should be diverted away from the filler or aseptic surge tank by means of the flow-diversion system. If for any reason the product is filled into containers, the product shall be segregated from product that received the scheduled process. The processing deviation shall be handled in accordance with \u00a7 113.89. Product flow to the filler or to the aseptic surge tank shall not be resumed until the cause of the improper pressure relationships in the regenerator has been corrected and the affected system(s) has been returned to a condition of commercial sterility.\n\n(D)  Loss of sterile air pressure or other protection level in the aseptic surge tank.  When an aseptic surge tank is used, conditions of commercial sterility may be lost when the sterile air overpressure or other means of protection drops below the scheduled process value. Product flow to and/or from the aseptic surge tank shall not be resumed until the potentially contaminated product in the tank is removed, and the aseptic surge tank has been returned to a condition of commercial sterility.\n\n(E)  Records.  Readings at the following points shall be observed and recorded at the start of aseptic packaging operations and at intervals of sufficient frequency to ensure that these values are as specified in the scheduled process: Temperature-indicating device in holding tube outlet; temperature-recording device in holding tube outlet; differential pressure recorder-controller, if a product-to-product regenerator is used; product flow rate as established by the flow control device or as determined by filling and closing rates and, if an aseptic surge tank is used, sterile air pressure or other protection means; and proper performance of steam seals or other similar devices. The measurements and recordings should be made at intervals not to exceed 1 hour.\n\n(2)  Container sterilizing, filling, and closing operation \u2014(i)  Equipment \u2014(A)  Recording device.  The container and closure sterilization system and product filling and closing system shall be instrumented to demonstrate that the required sterilization is being accomplished continuously. Recording devices shall be used to record, when applicable, the sterilization media flow rates, temperature, concentration, or other factors. When a batch system is used for container sterilization, the sterilization conditions shall be recorded.\n\n(B)  Timing method(s).  A method(s) shall be used either to give the retention time of containers, and closures if applicable, in the sterilizing environment specified in the scheduled process, or to control the sterilization cycle at the rate specified in the scheduled process. A means of preventing unauthorized speed changes must be provided. A lock or a notice from management posted at or near the speed adjusting device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.\n\n(ii)  Operation \u2014(A)  Startup.  Before the start of packaging operations, both the container and closure sterilizing system and the product filling and closing system shall be brought to a condition of commercial sterility.\n\n(B)  Loss of sterility.  A system shall be provided to stop packaging operations, or alternatively to ensure segregation of any product packaged when the packaging conditions fall below scheduled processes. Compliance with this requirement may be accomplished by diverting product away from the filler, by preventing containers from entering the filler, or by other suitable means. In the event product is packaged under conditions below those specified in the scheduled process, all such product shall be segregated from product that received the scheduled process. The processing deviation shall be handled in accordance with \u00a7 113.89. In the event of loss of sterility, the system(s) shall be returned to a condition of commercial sterility before resuming packaging operations.\n\n(C)  Records.  Observations and measurements of operating conditions shall be made and recorded at intervals of sufficient frequency to ensure that commercial sterility of the food product is being achieved; such measurements shall include the sterilization media flow rates, temperatures, the container and closure rates (if applicable) through the sterilizing system, and the sterilization conditions if a batch system is used for container sterilization. The measurements and recordings should be made at intervals not to exceed 1 hour.\n\n(3)  Incubation.  Incubation tests should be conducted on a representative sample of containers of product from each code; records of the test results should be maintained.\n\n(4)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. Such measurements and recordings should be done at intervals not to exceed 15 minutes.\n\n(h)  Equipment and procedures for flame sterilizers.  The container conveyor speed shall be specified in the scheduled process. The container conveyor speed shall be measured and recorded at the start of operations and at intervals of sufficient frequency to ensure that the conveyor speed is as specified in the scheduled process. Such measurements and recordings should be done at 1-hour intervals. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. A means of preventing changes in flame intensity and unauthorized speed changes on the conveyor shall be provided. A lock or a notice from management posted at or near the speed adjusting device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes. The surface temperature of at least one container from each conveyor channel shall be measured and recorded at the entry and at the end of the holding period at intervals of sufficient frequency to ensure that the temperatures specified in the scheduled process are maintained. Such measurements and recordings should be done at intervals not to exceed 15 minutes.\n\n(1)  Process interruption.  In the event of process interruption wherein the temperature of the product may have dropped, an authorized, scheduled emergency plan approved by a qualified person having expert knowledge of the process requirements may be used.\n\n(2)  Critical factors.  Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process.\n\n(i)  Equipment and procedures for thermal processing of foods wherein critical factors such as water activity are used in conjunction with thermal processing.  The methods and controls used for the manufacture, processing, and packing of such foods shall be as established in the scheduled process and shall be operated or administered in a manner adequate to ensure that the product is safe. The time and temperature of processing and other critical factors specified in the scheduled process shall be measured with instruments having the accuracy and dependability adequate to ensure that the requirements of the scheduled process are met. All measurements shall be made and recorded at intervals of sufficient frequency to ensure that the critical factors are within the limits specified in the scheduled process.\n\n(j)  Other systems.  All systems, whether or not specifically mentioned in this part, for the thermal processing of low-acid foods in hermetically sealed containers shall conform to the applicable requirements of this part and the methods and controls used for the manufacture, processing, and packing of these foods shall be as established in the scheduled process. These systems shall be operated or administered in a manner adequate to ensure that commercial sterility is achieved. Critical factors specified in the scheduled process shall be measured and recorded at intervals of sufficient frequency to ensure that the critical factors are within the limits specified in the scheduled process."], ["21:21:2.0.1.1.13.4.1.1", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "D", "Subpart D\u2014Control of Components, Food Product Containers, Closures, and In-Process Materials", "", "\u00a7 113.60 Containers.", "FDA", "", "", "[44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11922, Mar. 3, 2011]", "(a)  Closures.  Regular observations shall be maintained during production runs for gross closure defects. Any such defects shall be recorded and corrective action taken and recorded. At intervals of sufficient frequency to ensure proper closure, the operator, closure supervisor, or other qualified container closure inspection person shall visually examine either the top seam of a can randomly selected from each seaming head or the closure of any other type of container being used and shall record the observations made. For double-seam cans, each can should be examined for cutover or sharpness, skidding or deadheading, false seam, droop at the crossover or lap, and condition of inside of countersink wall for evidence of broken chuck. Such measurements and recordings should be made at intervals not to exceed 30 minutes. Additional visual closure inspections shall be made immediately following a jam in a closing machine, after closing machine adjustment, or after startup of a machine following a prolonged shutdown. All pertinent observations shall be recorded. When irregularities are found, the corrective action shall be recorded.\n\n(1) Teardown examinations for double-seam cans shall be performed by a qualified individual and the results therefrom shall be recorded at intervals of sufficient frequency on enough containers from each seaming station to ensure maintenance of seam integrity. Such examinations and recordings should be made at intervals not to exceed 4 hours. The results of the teardown examinations shall be recorded and the corrective action taken, if any, shall be noted.\n\n(i) Required and optional can seam measurements:\n\n( a ) Micrometer measurement system:\n\n( b ) Seam scope or projector:\n\n( c ) Can double seam terminology:\n\n( 1 ) \u201cCrossover\u201d: The portion of a double seam at the lap.\n\n( 2 ) \u201cCutover\u201d: A fracture, sharp bend, or break in the metal at the top of the inside portion of the double seam.\n\n( 3 ) \u201cDeadhead\u201d: A seam which is incomplete due to chuck spinning in the countersink.\n\n( 4 ) \u201cDroop\u201d: Smooth projection of double seam below bottom of normal seam.\n\n( 5 ) \u201cFalse seam\u201d: A small seam breakdown where the cover hook and the body hook are not overlapped.\n\n( 6 ) \u201cLap\u201d: Two thicknesses of material bonded together.\n\n(ii) Two measurements at different locations, excluding the side seam, shall be made for each double seam characteristic if a seam scope or seam projector is used. When a micrometer is used, three measurements shall be made at points approximately 120\u00b0 apart, excluding the side seam.\n\n(iii) Overlap length can be calculated by the following formula:\n\nThe theoretical overlap length = CH + BH + T \u2212 W, where\n\nCH = cover hook\n \n BH = body hook\n \n T = cover thickness, and\n \n W = seam width (height, length)\n\nCH = cover hook\n\nBH = body hook\n\nT = cover thickness, and\n\nW = seam width (height, length)\n\n(2) For glass containers with vacuum closures, capper efficiency must be checked by a measurement of the cold water vacuum. This shall be done before actual filling operations, and the results shall be recorded.\n\n(3) For closures other than double seams and glass containers, appropriate detailed inspections and tests shall be conducted by qualified personnel at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production. Records of such tests shall be maintained.\n\n(b)  Cooling water.  Container cooling water shall be chlorinated or otherwise sanitized as necessary for cooling canals and for recirculated water supplies. There should be a measurable residual of the sanitizer employed at the water discharge point of the container cooler.\n\n(c)  Coding.  Each hermetically sealed container of low-acid processed food shall be marked with an identifying code that shall be permanently visible to the naked eye. When the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, if the label is securely affixed to the product container. The required identification shall identify in code the establishment where packed, the product contained therein, the year packed, the day packed, and the period during which packed. The packing period code shall be changed with sufficient frequency to enable ready identification of lots during their sale and distribution. Codes may be changed on the basis of one of the following: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers that constitute the batch do not extend over a period of more than one personnel shift.\n\n(d)  Postprocess handling.  Container handling equipment used in handling filled containers shall be designed, constructed, and operated to preserve the can seam or other container closure integrity. Container handling equipment, including automated and non-automated equipment, shall be checked with sufficient frequency and repaired or replaced as necessary to prevent damage to containers and container closures. When cans are handled on belt conveyors, the conveyors should be constructed to minimize contact by the belt with the double seam,  i.e.,  cans should not be rolled on the double seam. All worn and frayed belting, can retarders, cushions,  etc.  should be replaced with new nonporous material. All tracks and belts that come into contact with the can seams should be thoroughly scrubbed and sanitized at intervals of sufficient frequency to avoid product contamination."], ["21:21:2.0.1.1.13.5.1.1", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "E", "Subpart E\u2014Production and Process Controls", "", "\u00a7 113.81 Product preparation.", "FDA", "", "", "", "(a) Before using raw materials and ingredients susceptible to microbiological contamination, the processor shall ensure that those materials and ingredients are suitable for use in processing low-acid food. Compliance with this requirement may be accomplished by receiving the raw materials and ingredients under a supplier's guarantee that they are suitable for use, by examining them for their microbiological condition, or by other acceptable means.\n\n(b) Blanching by heat, when required in the preparation of food for canning, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent processing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by cleaning. If the blanched food product is washed before filling, potable water should be used.\n\n(c) The filling of containers, either mechanically or by hand, shall be controlled so as to ensure that the filling requirements specified in the scheduled process are met.\n\n(d) The exhausting of containers for the removal of air shall be controlled so as to meet the conditions for which the process was designed. Compliance with the requirement may be accomplished by heat exhausting, mechanical exhausting, hot brining, or steam injection.\n\n(e) When the maintenance of pH (above 4.6) of a normally low-acid food is a basis for a scheduled process, there shall be careful supervision to ensure that the equilibrium pH of the finished product meets that of the scheduled process. The methodology described in \u00a7 114.90 of this chapter should be used.\n\n(f) When the scheduled process sets forth critical factors to prevent the growth of microorganisms not destroyed by the thermal process, the factors shall be carefully controlled to ensure that the limits established in the scheduled process are not exceeded. When normally low-acid foods require sufficient solute to permit safe processing at low temperatures, such as in boiling water, there shall be careful supervision to ensure that the equilibrium water activity (a w ) of the finished product meets that of the scheduled process. The scheduled thermal processes for foods having an a w  greater than 0.85 and less than the a w  that would allow the growth of spores of microorganisms of public health significance shall be sufficient to render the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution."], ["21:21:2.0.1.1.13.5.1.2", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "E", "Subpart E\u2014Production and Process Controls", "", "\u00a7 113.83 Establishing scheduled processes.", "FDA", "", "", "[76 FR 11922, Mar. 3, 2011]", "Scheduled processes for low-acid foods shall be established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations. The type, range, and combination of variations encountered in commercial production shall be adequately provided for in establishing the scheduled process. Variations include those that occur due to seasonal or growing fluctuations, variety differences, supplier processes, reprocessing, and mixing a batch of processed product with the same unprocessed product before it is processed. Critical factors, e.g., minimum headspace, consistency, maximum fill-in or drained weight, a w ,  etc.,  that may affect the scheduled process, shall be specified in the scheduled process. Acceptable scientific methods of establishing heat sterilization processes shall include, when necessary, but shall not be limited to, the use of microbial thermal death time data, process calculations based on product heat penetration data, and inoculated packs. Calculation shall be performed according to procedures recognized by competent processing authorities. If incubation tests are necessary for process confirmation, they shall include containers from test trials and from actual commercial production runs during the period of instituting the process. The incubation tests for confirmation of the scheduled processes should include the containers from the test trials and a number of containers from each of four or more actual commercial production runs. The number of containers from actual commercial production runs should be determined on the basis of recognized scientific methods to be of a size sufficient to ensure the adequacy of the process. Complete records covering all aspects of the establishment of the process and associated incubation tests shall be prepared and shall be permanently retained by the person or organization making the determination."], ["21:21:2.0.1.1.13.5.1.3", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "E", "Subpart E\u2014Production and Process Controls", "", "\u00a7 113.87 Operations in the thermal processing room.", "FDA", "", "", "[44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11923, Mar. 3, 2011]", "(a) Operating processes and retort venting procedures to be used for each product and container size being packed shall either be posted in a conspicuous place near the processing equipment or be made readily available to the retort or processing system operator and any duly authorized employee of the Food and Drug Administration. Scheduled processes must be made readily available to the supervisor and any duly authorized employee of the Food and Drug Administration.\n\n(b) A system for product traffic control in the retort room shall be established to prevent unretorted product from bypassing the retort process. Each retort basket, truck, car, or crate used to hold containers in a retort, or one or more containers therein, shall, if it contains any retorted food product, be plainly and conspicuously marked with a heat-sensitive indicator, or by other effective means that will indicate visually, to thermal processing personnel, those units that have been retorted. A visual check shall be performed to determine whether or not the appropriate change has occurred in the heat-sensitive indicator as a result of retorting for all retort baskets, trucks, cars, or crates, to ensure that each unit of product has been retorted. A record of these checks should be made.\n\n(c) The initial temperature of the contents of the containers to be processed shall be accurately determined and recorded with sufficient frequency to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process. For those operations that use water during the filling of the retort or during processing, provision shall be made to ensure that the water will not, before the start of each thermal process, lower the initial temperature of the product below that specified in the scheduled process. The temperature-indicating device used to determine the initial temperature shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device, by appropriate standard procedures, with sufficient frequency to ensure that initial temperature measurements are accurate. Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with \u00a7 113.100(c) and (d).\n\n(d) Timing devices used in recording thermal process time information shall be accurate to the extent needed to ensure that the processing time and venting time specified in the scheduled process are achieved. Pocket or wrist watches are not considered satisfactory for timing purposes. Digital clocks may be used if the operating process and the venting schedule have a 1-minute or greater safety factor over the scheduled process.\n\n(e) Clock times on temperature-recording device records shall reasonably correspond to the time of day on the processing records to provide correlation of these records.\n\n(f) The steam supply to the thermal processing system shall be adequate to the extent needed to ensure that sufficient steam pressure is maintained during thermal processing, regardless of other demands of steam by the plant.\n\n(g) If mufflers are used on bleeders or vent systems, evidence that the bleeders or vents are operated in a manner that does not significantly impede the removal of air shall be kept on file. This evidence may be in the form of heat distribution data or other satisfactory evidence such as a letter from the manufacturer, the designer, or a competent processing authority."], ["21:21:2.0.1.1.13.5.1.4", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "E", "Subpart E\u2014Production and Process Controls", "", "\u00a7 113.89 Deviations in processing, venting, or control of critical factors.", "FDA", "", "", "", "Whenever any process is less than the scheduled process or when critical factors are out of control for any low-acid food or container system as disclosed from records by processor check or otherwise, the commercial processor of that low-acid food shall either fully reprocess that portion of the production involved, keeping full records of the reprocessing conditions or, alternatively, must set aside that portion of the product involved for further evaluation as to any potential public health significance. Such evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Unless this evaluation demonstrates that the product had been given a thermal process that rendered it free of microorganisms of potential public health significance, the product set aside shall be either fully reprocessed to render it commercially sterile or destroyed. A record shall be made of the evaluation procedures used and the results. Either upon completion of full reprocessing and the attainment of commercial sterility or after the determination that no significant potential for public health hazard exists, that portion of the product involved may be shipped in normal distribution. Otherwise, the portion of the product involved shall be destroyed. All process deviations involving a failure to satisfy the minimum requirements of the scheduled process, including emergencies arising from a jam or breakdown of a continuous agitating retort necessitating cooling the retort for repairs, shall be recorded and made the subject of a separate file (or a log identifying the appropriate data) detailing those deviations and the actions taken."], ["21:21:2.0.1.1.13.6.1.1", 21, "Food and Drugs", "I", "B", "113", "PART 113\u2014THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS", "F", "Subpart F\u2014Records and Reports", "", "\u00a7 113.100 Processing and production records.", "FDA", "", "", "[44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11923, Mar. 3, 2011]", "(a) Processing and production information shall be entered at the time it is observed by the retort or processing system operator, or other designated person, on forms that include the product, the code number, the date, the retort or processing system number, the size of container, the approximate number of containers per coding interval, the initial temperature, the actual processing time, the temperature-indicating device and temperature-recording device readings, and other appropriate processing data. Closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, or other critical factors specified in the scheduled process shall also be recorded. In addition, the following records shall be maintained:\n\n(1)  Still retorts.  Time steam on; time temperature up to processing temperature; time steam off; venting time and temperature to which vented.\n\n(2)  Agitating retorts.  Functioning of condensate bleeder; retort speed; and, when specified in the scheduled process, headspace, consistency, maximum drained weight, minimum net weight, and percent solids.\n\n(3)  Hydrostatic retorts.  The temperature in the steam chamber between the steam-water interface and the lowest container position; speed of the container conveyor chain; and, when the scheduled process specifies maintenance of particular temperatures in the hydrostatic water legs, the temperatures near the top and the bottom of each hydrostatic water leg.\n\n(4)  Aseptic processing and packaging systems.  Product temperature in the holding tube outlet as indicated by the temperature-indicating device and the temperature-recording device; differential pressure as indicated by the differential pressure recorder-controller, if a product-to-product regenerator is used; product flow rate, as determined by the flow controlling device or by filling and closing rates; sterilization media flow rate or temperature or both; retention time of containers, and closures when applicable, in the sterilizing environment; and, when a batch system is used for container and/or closure sterilization, sterilization cycle times and temperatures.\n\n(5)  Flame sterilizers.  Container conveyor speed; surface temperature at the beginning and at the end of the holding period; nature of container.\n\n(6)  Food preservation methods wherein critical factors such as water activity are used in conjunction with thermal processing.  Product formulation and scheduled processes used, including the thermal process, its associated critical factors, as well as other critical factors, and results of a w  determinations.\n\n(7)  Other systems.  Critical factors specified in the formulation of the product or in the scheduled process.\n\n(b) Temperature-recording device records shall be identified by date, retort number, and other data as necessary, so they can be correlated with the record of lots processed. Each entry on the processing and production records shall be made by the retort or processing system operator, or other designated person, at the time the specific retort or processing system condition or operation occurs, and this retort or processing system operator or other designated person shall sign or initial each record form. Not later than 1 working day after the actual process, and before shipment or release for distribution, a representative of plant management who is qualified by suitable training or experience shall review all processing and production records for completeness and to ensure that the product received the scheduled process. The records, including temperature-recording device records, shall be signed or initialed and dated by the reviewer.\n\n(c) Records of the accuracy of a temperature-indicating device shall include:\n\n(1) A reference to the tag, seal, or other means of identity used by the processor to identify the temperature-indicating device;\n\n(2) The name of the manufacturer of the temperature-indicating device;\n\n(3) The identity of the reference device, equipment, and procedures used for the accuracy test and to adjust the temperature-indicating device or, if an outside facility is used to conduct the accuracy test for the temperature-indicating device, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a National Institute of Standards and Technology (NIST) or other national metrology institute standard;\n\n(4) The identity of the person or facility that performed the accuracy test and adjusted or calibrated the temperature-indicating device;\n\n(5) The date and results of each accuracy test, including the amount of calibration adjustment; and\n\n(6) The date on or before which the next accuracy test must be performed.\n\n(d) Records of the accuracy of a reference device maintained by the processor shall include:\n\n(1) A reference to the tag, seal, or other means of identity used by the processor to identify the reference device;\n\n(2) The name of the manufacturer of the reference device;\n\n(3) The identity of the equipment and reference to procedures used for the accuracy test and to adjust or calibrate the reference device or, if an outside facility is used to conduct the accuracy test for the reference device, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a NIST or other national metrology institute standard;\n\n(4) The identity of the person or facility that performed the accuracy test and adjusted or calibrated the reference device;\n\n(5) The date and results of each accuracy test, including the amount of calibration adjustment; and\n\n(6) The date on or before which the next accuracy test must be performed.\n\n(e) Records of all container closure examinations shall specify the product code, the date and time of container closure inspections, the measurements obtained, and all corrective actions taken. Records shall be signed or initialed by the container closure inspector and reviewed by management with sufficient frequency to ensure that the containers are hermetically sealed. The records shall be signed or initialed and dated by the reviewer.\n\n(f) Records shall be maintained to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use.\n\n(g) Copies of all records provided for in this part, except those required under \u00a7 113.83 establishing scheduled processes, shall be retained at the processing plant for a period of not less than 1 year from the date of manufacture, and at the processing plant or other reasonably accessible location for an additional 2 years. If, during the first year of the 3-year record-retention period, the processing plant is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack.\n\n(h) Records of this part may be maintained electronically, provided they are in compliance with part 11 of this chapter."], ["40:40:24.0.1.1.8.1.6.1", 40, "Protection of Environment", "I", "D", "113", "PART 113\u2014LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES", "A", "Subpart A\u2014Oil Storage Facilities", "", "\u00a7 113.1 Purpose.", "EPA", "", "", "", "This subpart establishes size classifications and associated liability limits for small onshore oil storage facilities with fixed capacity of 1,000 barrels or less."], ["40:40:24.0.1.1.8.1.6.2", 40, "Protection of Environment", "I", "D", "113", "PART 113\u2014LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES", "A", "Subpart A\u2014Oil Storage Facilities", "", "\u00a7 113.2 Applicability.", "EPA", "", "", "", "This subpart applies to all onshore oil storage facilities with fixed capacity of 1,000 barrels or less. When a discharge to the waters of the United States occurs from such facilities and when removal of said discharge is performed by the United States Government pursuant to the provisions of subsection 311(c)(1) of the Act, the liability of the owner or operator and the facility will be limited to the amounts specified in \u00a7 113.4."], ["40:40:24.0.1.1.8.1.6.3", 40, "Protection of Environment", "I", "D", "113", "PART 113\u2014LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES", "A", "Subpart A\u2014Oil Storage Facilities", "", "\u00a7 113.3 Definitions.", "EPA", "", "", "", "As used in this subpart, the following terms shall have the meanings indicated below:\n\n(a)  Aboveground  storage facility means a tank or other container, the bottom of which is on a plane not more than 6 inches below the surrounding surface.\n\n(b)  Act  means the Federal Water Pollution Control Act, as amended, 33 U.S.C. 1151,  et seq.\n\n(c)  Barrel  means 42 United States gallons at 60 degrees Fahrenheit.\n\n(d)  Belowground  storage facility means a tank or other container located other than as defined as \u201cAboveground\u201d.\n\n(e)  Discharge  includes, but is not limited to any spilling, leaking, pumping, pouring, emitting, emptying or dumping.\n\n(f)  Onshore Oil Storage Facility  means any facility (excluding motor vehicles and rolling stock) of any kind located in, on, or under, any land within the United States, other than submerged land.\n\n(g)  On-Scene Coordinator  is the single Federal representative designated pursuant to the National Oil and Hazardous Substances Pollution Contingency Plan and identified in approved Regional Oil and Hazardous Substances Pollution Contingency Plans.\n\n(h)  Oil  means oil of any kind or in any form, including but not limited to, petroleum, fuel oil, sludge, oil refuse, and oil mixed with wastes other than dredged spoil.\n\n(i)  Remove  or  removal  means the removal of the oil from the water and shorelines or the taking of such other actions as the Federal On-Scene Coordinator may determine to be necessary to minimize or mitigate damage to the public health or welfare, including but not limited to, fish, shellfish, wildlife, and public and private property, shorelines, and beaches.\n\nAdditionally, the terms not otherwise defined herein shall have the meanings assigned them by section 311(a) of the Act."], ["40:40:24.0.1.1.8.1.6.4", 40, "Protection of Environment", "I", "D", "113", "PART 113\u2014LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES", "A", "Subpart A\u2014Oil Storage Facilities", "", "\u00a7 113.4 Size classes and associated liability limits for fixed onshore oil storage facilities, 1,000 barrels or less capacity.", "EPA", "", "", "", "Unless the United States can show that oil was discharged as a result of willful negligence or willful misconduct within the privity and knowledge of the owner or operator, the following limits of liability are established for fixed onshore facilities in the classes specified:\n\n(a) Aboveground storage.\n\n(b) Belowground storage."], ["40:40:24.0.1.1.8.1.6.5", 40, "Protection of Environment", "I", "D", "113", "PART 113\u2014LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES", "A", "Subpart A\u2014Oil Storage Facilities", "", "\u00a7 113.5 Exclusions.", "EPA", "", "", "", "This subpart does not apply to:\n\n(a) Those facilities whose average daily oil throughout is more than their fixed oil storage capacity.\n\n(b) Vehicles and rolling stock."], ["40:40:24.0.1.1.8.1.6.6", 40, "Protection of Environment", "I", "D", "113", "PART 113\u2014LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES", "A", "Subpart A\u2014Oil Storage Facilities", "", "\u00a7 113.6 Effect on other laws.", "EPA", "", "", "", "Nothing herein shall be construed to limit the liability of any facility under State or local law or under any Federal law other than section 311 of the Act, nor shall the liability of any facility for any charges or damages under State or local law reduce its liability to the Federal Government under section 311 of the Act, as limited by this subpart."], ["46:46:4.0.1.3.17.1.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.05", "Subpart 113.05\u2014General Provisions", "", "\u00a7 113.05-5 Approved equipment.", "USCG", "", "", "", "If approved equipment is required in this part, that equipment must be specifically approved by the Commandant.\n\nMany specifications for equipment that must be approved are in Subchapter Q for this chapter."], ["46:46:4.0.1.3.17.1.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.05", "Subpart 113.05\u2014General Provisions", "", "\u00a7 113.05-7 Environmental tests.", "USCG", "", "", "[USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "(a) Communication, alarm system, control, and monitoring equipment, with the exception of fire and smoke detection and alarm systems, must meet the environmental tests of\u2014\n\n(1) Section 4-9-9, Table 1, of ABS Marine Vessel Rules (incorporated by reference; see \u00a7 110.10-1 of this subchapter) or the applicable ENV category of Lloyd's Register Type Approval System\u2014Test Specification Number 1 (incorporated by reference; see \u00a7 110.10-1 of this subchapter); and\n\n(2) IEC 60533:2015 (incorporated by reference; see \u00a7 110.10-1 of this subchapter) as appropriate.\n\n(b) Components of smoke detection and alarm systems must be tested in accordance with 46 CFR 161.002."], ["46:46:4.0.1.3.17.10.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.43", "Subpart 113.43\u2014Steering Failure Alarm Systems", "", "\u00a7 113.43-1 Applicability.", "USCG", "", "", "", "This subpart applies to each vessel of 1600 gross tons and over that has power driven main or auxiliary steering gear."], ["46:46:4.0.1.3.17.10.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.43", "Subpart 113.43\u2014Steering Failure Alarm Systems", "", "\u00a7 113.43-3 Alarm system.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 62 FR 23910, May 1, 1997; USCG-2004-18884, 69 FR 58348, Sept. 30, 2004]", "(a) Each vessel must have a steering failure alarm system that actuates an audible and visible alarm in the pilothouse when the actual position of the rudder differs by more than 5 degrees from the rudder position ordered by the followup control systems, required by part 58, subpart 58.25, of this chapter, for more than:\n\n(1) 30 seconds for ordered rudder position changes of 70 degrees;\n\n(2) 6.5 seconds for ordered rudder position changes of 5 degrees; and\n\n(3) The time period calculated by the following formula for ordered rudder positions changes between 5 degrees and 70 degrees:\n\nt = (R/2.76) + 4.64\n\nWhere\n \n t = maximum time delay in seconds\n \n R = ordered rudder change in degrees\n\nWhere\n\nt = maximum time delay in seconds\n\nR = ordered rudder change in degrees\n\n(b) The alarm system must be separate from, and independent of, each steering gear control system, except for input received from the steering wheel shaft."], ["46:46:4.0.1.3.17.10.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.43", "Subpart 113.43\u2014Steering Failure Alarm Systems", "", "\u00a7 113.43-5 Power supply.", "USCG", "", "", "", "Each steering failure alarm system must be supplied by a circuit that:\n\n(a) Is independent of other steering gear system and steering alarm circuits;\n\n(b) Is fed from the final emergency power source through the emergency distribution panel in the wheelhouse, if installed; and\n\n(c) Has no overcurrent protection except short-circuit protection by an instantaneous fuse or circuit breaker rated or set at 400 to 500 percent of:\n\n(1) The current-carrying capacity of the smallest alarm system interconnecting conductors; or\n\n(2) The normal load of the system."], ["46:46:4.0.1.3.17.11.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.45", "Subpart 113.45\u2014Refrigerated Spaces Alarm Systems", "", "\u00a7 113.45-5 General requirements.", "USCG", "", "", "", "(a) Each refrigerated space that is accessible to the vessel's personnel and that can be locked from the outside so that it cannot be opened from the inside, must have an audible alarm system that can be operated from within the refrigerated space.\n\n(b) The alarm activator must be in the refrigerated space at its exit.\n\n(c) The audible signal must sound at a manned location.\n\n(d) If there is a common audible signal for more than one lockable refrigerated space, there must be an annunciator for locating the space from which the signal was initiated."], ["46:46:4.0.1.3.17.12.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.50", "Subpart 113.50\u2014Public Address Systems", "", "\u00a7 113.50-1 Applicability.", "USCG", "", "", "[CGD 94-108, 61 FR 28290, June 4, 1996]", "This subpart applies to each vessel required to have a general emergency alarm system in accordance with \u00a7 113.25-1."], ["46:46:4.0.1.3.17.12.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.50", "Subpart 113.50\u2014Public Address Systems", "", "\u00a7 113.50-5 General requirements.", "USCG", "", "", "[CGD 94-108, 61 FR 28290, June 4, 1996, as amended at 62 FR 23910, May 1, 1997; USCG-2003-16630, 73 FR 65202, Oct. 31, 2008; USCG-2020-0075, 88 FR 16369, Mar. 16, 2023; 88 FR 25285, Apr. 26, 2023]", "(a) Each vessel must have an amplifier-type announcing system that will supplement the general emergency alarm. This system must provide for the transmission of orders and information throughout the vessel by means of microphones and loudspeakers connected through an amplifier. If a decentralized-type system is used, its overall performance must not be affected by the failure of a single call station. This system may be combined with the general emergency alarm and fire detecting and alarm systems. The public address system must be protected against unauthorized use.\n\n(b) The announcing station must be located adjacent to the general emergency alarm contact maker or initiating device on the navigating bridge.\n\n(c) There must be a means to silence all other audio distribution systems at the announcing station.\n\n(d) The system may be arranged to allow broadcasting separately to, or to any combination of, various areas on the vessel. If the amplifier system is used for the general emergency alarm required by subpart 113.25 of this part, the operation of a general emergency alarm contact maker or initiating device must activate all speakers in the system, except that a separate crew alarm may be used as allowed by \u00a7 113.25-5(e)(2).\n\n(e) The amplifier, and any device used to produce the general emergency alarm signal, must be provided in duplicate.\n\n(f) The power supply must be in accordance with the requirements of \u00a7\u00a7 113.25-6 and 113.25-7.\n\n(g) Each electrical subsystem in a weather location must be watertight or in a watertight enclosure and must meet Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013 (both incorporated by reference; see \u00a7 110.10-1 of this subchapter) requirements."], ["46:46:4.0.1.3.17.12.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.50", "Subpart 113.50\u2014Public Address Systems", "", "\u00a7 113.50-10 Additional requirements for passenger vessels.", "USCG", "", "", "[CGD 94-108, 61 FR 28290, June 4, 1996]", "Each passenger vessel must have a public address system capable of broadcasting separately or collectively to the following stations:\n\n(a) Survival craft stations, port.\n\n(b) Survival craft stations, starboard.\n\n(c) Survival craft embarkation stations, port.\n\n(d) Survival craft embarkation stations, starboard.\n\n(e) Public spaces used for passenger assembly points.\n\n(f) Crew quarters.\n\n(g) Accommodation spaces and service spaces."], ["46:46:4.0.1.3.17.12.45.4", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.50", "Subpart 113.50\u2014Public Address Systems", "", "\u00a7 113.50-15 Loudspeakers.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28291, June 4, 1996; 61 FR 36787, July 12, 1996]", "(a) Loudspeakers must be located to eliminate feedback or other interference which would degrade communication.\n\n(b) Loudspeakers must be located to provide intelligible and audible one-way communication throughout the vessel. Weatherdeck loudspeakers must be watertight and suitably protected from the effects of the wind and seas.\n\n(c) There must be a sufficient number of loudspeakers throughout the vessel. The public address system must be installed with regard to acoustically marginal conditions and not require any action from the addressee. With the vessel underway in normal conditions, the minimum sound pressure levels for broadcasting emergency announcements must be\u2014\n\n(1) In interior spaces, 75 dB(A) or, if the background noise level exceeds 75 dB(A), then at least 20 dB(A) above maximum background noise level; and\n\n(2) In exterior spaces, 80 dB(A) or, if the background noise level exceeds 80 dB(A), then at least 15 dB(A) above maximum background noise level.\n\n(d) Loudspeakers must not have external volume controls or local cutout switches."], ["46:46:4.0.1.3.17.12.45.5", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.50", "Subpart 113.50\u2014Public Address Systems", "", "\u00a7 113.50-20 Distribution of cable runs.", "USCG", "", "", "[CGD 94-108, 61 FR 28291, June 4, 1996]", "(a) Each system must have a feeder distribution panel to divide the system into the necessary number of zone feeders. Where, because of the arrangement of the vessel, only one zone feeder is necessary, a branch circuit distribution panel must be used.\n\n(b) The feeder distribution panel must be in an enclosed space next to the public address system power supply.\n\n(c) Each system must have at least one feeder for each vertical fire zone.\n\n(d) Each system must have one or more branch circuit distribution panels for each zone feeder, with at least one branch circuit for each deck level. The distribution panel must be above the uppermost continuous deck, in the zone served, and there must be no disconnect switches for the branch circuits.\n\n(e) A branch circuit must not supply speakers on more than one deck level, except for a single branch circuit supplying all levels of a single space if all other requirements of this section are met.\n\n(f) On a vessel not divided into vertical fire zones by main vertical fire bulkheads, the vessel must be divided into vertical zones not more than 40 meters (131 feet) long. There must be a feeder for each of these zones.\n\n(g) Feeders and branch circuit cables must be in passageways. They must not be in staterooms, lockers, galleys, or machinery spaces, unless it is necessary to supply public address speakers in those spaces."], ["46:46:4.0.1.3.17.13.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.65", "Subpart 113.65\u2014Whistle Operators", "", "\u00a7 113.65-5 General requirements.", "USCG", "", "", "[USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "Each whistle operator must meet Section 18 of IEEE 45.1-2017 (incorporated by reference; see \u00a7 110.10-1 of this subchapter)."], ["46:46:4.0.1.3.17.2.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.10", "Subpart 113.10\u2014Fire and Smoke Detecting and Alarm Systems", "", "\u00a7 113.10-1 Approved equipment.", "USCG", "", "", "", "Each alarm annunciator, fire detector, test station, manual station, and vibrating bell must be approved under Subpart 161.002 of this chapter and meet the requirements of this subpart."], ["46:46:4.0.1.3.17.2.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.10", "Subpart 113.10\u2014Fire and Smoke Detecting and Alarm Systems", "", "\u00a7 113.10-3 Cable runs.", "USCG", "", "", "", "Cable runs between the fire alarm annunciator and fire detecting or fire alarm zones must be as direct as practicable and, where practicable, must not be in staterooms, lockers, or other enclosed spaces in order to reduce the risk of damage by a localized fire or other cause."], ["46:46:4.0.1.3.17.2.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.10", "Subpart 113.10\u2014Fire and Smoke Detecting and Alarm Systems", "", "\u00a7 113.10-5 Common return.", "USCG", "", "", "", "A conductor must not be used as a common return from more than one zone."], ["46:46:4.0.1.3.17.2.45.4", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.10", "Subpart 113.10\u2014Fire and Smoke Detecting and Alarm Systems", "", "\u00a7 113.10-7 Connection boxes.", "USCG", "", "", "[USCG-2003-16630, 73 FR 65201, Oct. 31, 2008; USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "Each connection box must be constructed in accordance with Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013 (both incorporated by reference; see 46 CFR 110.10-1) requirements."], ["46:46:4.0.1.3.17.2.45.5", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.10", "Subpart 113.10\u2014Fire and Smoke Detecting and Alarm Systems", "", "\u00a7 113.10-9 Power supply.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28288, June 4, 1996]", "(a)  General.  There must be at least two sources of power for the electrical equipment of each fire detecting and alarm system. The normal source must be the main power source. The other source must be the emergency power source or an automatically charged battery. If the other source is an automatically charged battery, the charger must be supplied from the final emergency power source. Upon loss of power to the system from the normal source, the system must be automatically supplied from the other source.\n\n(b)  Batteries.  Each battery used in a fire detecting and alarm system must meet Subpart 111.15 of this chapter.\n\n(c)  Capacity of power supply branch circuit.  The capacity of each branch circuit providing power to a fire detection or alarm system must not be less than 125 percent of the maximum load."], ["46:46:4.0.1.3.17.3.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.20", "Subpart 113.20\u2014Automatic Sprinkler Systems", "", "\u00a7 113.20-1 Sprinkler alarm system.", "USCG", "", "", "", "Each sprinkler alarm system, including annunciator, power supply, alarm switches, and bells, must meet Subpart 76.25 of this chapter."], ["46:46:4.0.1.3.17.3.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.20", "Subpart 113.20\u2014Automatic Sprinkler Systems", "", "\u00a7 113.20-3 Connection boxes.", "USCG", "", "", "[USCG-2003-16630, 73 FR 65201, Oct. 31, 2008, as amended by USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "Each connection box and each switch enclosure in an automatic sprinkler system must be constructed in accordance with Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013 (both incorporated by reference; see 46 CFR 110.10-1) requirements."], ["46:46:4.0.1.3.17.4.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-1 Applicability.", "USCG", "", "", "", "(a) This subpart, except \u00a7\u00a7 113.25-25 and 113.25-30, applies to each manned vessel of over 100 gross tons, except barges, scows, and similar vessels.\n\n(b) Section 113.25-25 applies to each manned ocean and coastwise barge of over 100 gross tons if the crew is divided into watches for the purpose of steering.\n\n(c) Section 113.25-30 applies to each barge of 300 or more gross tons that has sleeping accommodations for more than six persons."], ["46:46:4.0.1.3.17.4.45.10", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-12 Alarm signals.", "USCG", "", "", "[CGD 94-108, 61 FR 28289, June 4, 1996, as amended by USCG-2003-16300, 73 FR 65201, Oct. 31, 2008]", "(a) Each general emergency alarm signal must be an electrically-operated bell, klaxon, or other warning device capable of producing a signal or tone distinct from any other audible signal on the vessel.\n\n(b) Electronic devices used to produce the general emergency alarm signal must meet the requirements of subpart 113.50 of this part.\n\n(c)(1) The minimum sound-pressure levels for the emergency-alarm tone in interior and exterior spaces must be a sound level of not less than 80 dB(A) measured at 10 feet on the axis; and\n\n(2) At least 10 dB(A) measured at 10 feet on the axis, above the background noise level when the vessel is underway in moderate weather unless flashing red lights are used in accordance with 46 CFR 113.25-10(b).\n\n(d) Alarm signals intended for use in sleeping compartments may have a minimum sound level of 75 dB(A) measured 3 feet (1 meter) on axis, and at least 10 dB(A) measured 3 feet (1 meter) on axis, above ambient noise levels with the ship under way in moderate weather."], ["46:46:4.0.1.3.17.4.45.11", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-14 Electric cable and distribution fittings.", "USCG", "", "", "", "Each cable entrance to an emergency alarm signal or distribution fitting must be made watertight by a terminal or stuffing tube."], ["46:46:4.0.1.3.17.4.45.12", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-15 Distribution panels.", "USCG", "", "", "", "Each distribution panel must:\n\n(a) Be watertight;\n\n(b) Need a tool to be opened."], ["46:46:4.0.1.3.17.4.45.13", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-16 Overcurrent protection.", "USCG", "", "", "[CGD 94-108, 61 FR 28289, June 4, 1996]", "(a) Each fuse in a general emergency alarm system must meet the requirements of part 111, subpart 111.53, of this chapter.\n\n(b) Each overcurrent protection device must cause as wide a differential as possible between the rating of the branch circuit overcurrent protection device and that of the feeder overcurrent protection device.\n\n(c) The capacity of the feeder overcurrent device must be as near practicable to 200 percent of the load supplied. The capacity of a branch circuit overcurrent device must not be higher than 50 percent of the capacity of the feeder overcurrent device."], ["46:46:4.0.1.3.17.4.45.14", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-20 Marking of equipment.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by USCG-2004-18884, 69 FR 58348, Sept. 30, 2004]", "(a) Each general emergency alarm system fused switch and distribution panel must have a fixed nameplate on the outside of its cover that has a description of its function. The rating of fuses must also be shown on the outside of the cover of a fused switch.\n\n(b) Each general alarm contact maker must be marked \u201cGENERAL ALARM\u201d in red letters on a corrosion-resistant plate or on a sign.\n\n(c) A contact maker that operates only the general emergency alarm signal in crew quarters, machinery spaces, and work spaces must be marked \u201cCREW ALARM\u201d by the method described in paragraph (b) of this section.\n\n(d) Each general emergency alarm signal must be marked \u201cGENERAL ALARM\u2014WHEN EMERGENCY ALARM SIGNAL RINGS GO TO YOUR STATION\u201d in red letters at least \n 1/2  inch high.\n\n(e) Each general emergency alarm system distribution panel must have a directory attached to the inside of its cover giving the designation of each circuit, the area supplied by each circuit, and the rating of each circuit fuse."], ["46:46:4.0.1.3.17.4.45.15", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-25 General emergency alarm systems for manned ocean and coastwise barges.", "USCG", "", "", "", "A manned ocean or coastwise barge of more than 100 gross tons, if it is one that operates with the crew divided into watches for steering the vessel, must have an emergency alarm signal installation. The system must:\n\n(a) Have an automatically charged battery as the power source;\n\n(b) Have a manually operated contact maker at the steering station and in the crew accommodation area; and\n\n(c) Must meet the requirements of \u00a7 113.25.7 and \u00a7\u00a7 113.25-9 through 113.25-20 of this subpart."], ["46:46:4.0.1.3.17.4.45.16", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-30 General emergency alarm systems for barges of 300 or more gross tons with sleeping accommodations for more than six persons.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28289, June 4, 1996]", "The general emergency alarm system for a barge of 300 or more gross tons with sleeping accommodations for more than six persons must meet the requirements of Subpart 113.25, except as follows:\n\n(a) The number and location of contact makers must be determined by the design, service, and operation of the barge.\n\nContact makers in the primary work area, quarters area, galley and mess area, machinery spaces, and the navigating bridge or control area should be considered.\n\n(b) If a distribution panel cannot be above the uppermost continuous deck because of the design of the barge and is installed below the deck, it must be as near the deck as practicable."], ["46:46:4.0.1.3.17.4.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-3 Requirements.", "USCG", "", "", "", "Each vessel must have a general emergency alarm system that meets the requirements of this subpart."], ["46:46:4.0.1.3.17.4.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-5 Location of contact makers.", "USCG", "", "", "", "(a)  Passenger vessels and cargo and miscellaneous vessels.  Each passenger vessel, cargo vessel, and miscellaneous vessel must have a manually operated contact maker for the general emergency alarm system:\n\n(1) In the navigating bridge; and\n\n(2) At the feeder distribution panel if the general alarm power supply is not in or next to the navigating bridge.\n\n(b)  Tank vessels.  Each tank vessel must have a manually operated contact maker for the general emergency alarm system:\n\n(1) In the navigating bridge;\n\n(2) At the deck officers' quarters farthest from the engineroom;\n\n(3) in the engineroom;\n\n(4) At the location of the emergency means of stopping cargo transfer required under 33 CFR 155.780; and\n\n(5) At the feeder distribution panel if the general alarm power supply is not in or next to the navigating bridge.\n\n(c)  Mobile offshore drilling units.  Each mobile offshore drilling unit must have a manually operated contact maker for the general emergency alarm system:\n\n(1) In the main control room;\n\n(2) At the drilling console;\n\n(3) At the feeder distribution panel;\n\n(4) In the navigating bridge, if a navigating bridge is installed; and\n\n(5) In a routinely occupied space that is as far as practicable from all other contact makers.\n\n(d)  Additional contact maker.  A vessel must not have more than one other contact maker that operates the general emergency alarm system in addition to those required under paragraph (a), (b), or (c) of this section unless the installation of other contact makers has been accepted by the Commandant.\n\n(e)  Special system.  If a vessel has an emergency squad when operating, has a manual fire alarm system, or is an ocean-going passenger vessel, it must have:\n\n(1) An independent manually operated contact maker in the navigating bridge that is connected to operate only the general emergency alarm signal in crew's quarters and machinery spaces; or\n\n(2) A separate alarm system that sounds in the crew's quarters and machinery spaces."], ["46:46:4.0.1.3.17.4.45.4", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-6 Power supply.", "USCG", "", "", "[USCG-2003-16630, 73 FR 65201, Oct. 31, 2008]", "The emergency power source for the general emergency alarm system must meet the requirements of IMO SOLAS 74 (incorporated by reference; see 46 CFR 110.10-1), Regulation II-1/42 or II-1/43, as applicable."], ["46:46:4.0.1.3.17.4.45.5", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-7 Power supply overcurrent protection.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "(a) If the general emergency alarm system is the only load supplied by the general emergency alarm system battery or batteries, the battery or batteries must have an enclosed fused switch or circuit breaker that has a means of locking. The fused switched or circuit breaker must be outside of, and next to, the battery room or battery locker, and the capacity of the fuses or circuit breaker must be at least 200 percent of the connected load.\n\n(b) If the general emergency alarm system is supplied from an emergency or interior communication switchboard, or if duplicate general alarm batteries supply other loads, there must be a fused switch or circuit breaker supplying the general emergency alarm system that has a means of locking."], ["46:46:4.0.1.3.17.4.45.6", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-8 Distribution of general emergency alarm system feeders and branch circuits.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28288, June 4, 1996]", "(a) Each system must have a feeder distribution panel to divide the system into the necessary number of zone, feeders, except where, because of the arrangement of the vessel, only one zone feeder is necessary; then a branch circuit distribution panel or feeder distribution panel must be used.\n\n(b) The feeder distribution panel must have overcurrent protection for each zone feeder, but there must be no disconnect switches.\n\n(c) The feeder distribution panel must be in an enclosed space next to the general alarm power supply.\n\n(d) Each system must have at least one feeder for each vertical fire zone that has general emergency alarm signal.\n\n(e) Each system must have one or more branch circuit distribution panels for each zone feeder, with at least one fused branch circuit for each deck level. The distribution panel must be above the uppermost continuous deck, in the zone served, and there must be no disconnect switches for the branch circuits.\n\n(f) A branch circuit must not supply emergency alarm signal on more than one deck level, except for a single branch circuit supplying all levels of a single space containing more than one deck level if all other requirements of this section are met.\n\n(g) On a vessel not divided into fire zones by main vertical fire bulkheads, the general emergency alarm system must be arranged into vertical service zones not more than 40 meters (131 feet) long, and there must be a general alarm feeder for each of these zones that has general emergency alarm signal.\n\n(h) General alarm feeders and branch circuit cables must be in passageways and must not be in staterooms, lockers, galleys, machinery spaces, or other enclosed spaces, unless it is necessary to supply general emergency alarm signal in those spaces."], ["46:46:4.0.1.3.17.4.45.7", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-9 Location of general emergency alarm signal.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28288, June 4, 1996; USCG-2015-0867, 80 FR 62469, Oct. 16, 2015]", "General emergency alarm signal must:\n\n(a) Be located in passenger and crew quarters areas where they can alert persons in spaces where those persons may be maintaining, repairing, or operating equipment, stowing or drawing stores or equipment, or transiting, such as public spaces, work spaces, machinery spaces, workshops, galleys, emergency firepump room, bow thruster rooms, storage areas for paint, rope, and other stores, underdeck passageways in cargo areas, steering gear rooms, windlass rooms, holds of roll-on/roll-off vessels, and, except those that are accessible only through bolted manhole covers, duct keels with valve operators; and\n\n(b) Be audible in the spaces identified in paragraph (a) of this section with all normally closed doors and accesses closed; and\n\n(c) Be installed in cabins without loudspeaker installation. Other audible devices, such as electronic alarm transducers, are permitted."], ["46:46:4.0.1.3.17.4.45.8", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-10 Emergency red-flashing lights.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28288, June 4, 1996; 62 FR 23910, May 1, 1997]", "(a) In a space described in \u00a7 113.25-9(a), where the general emergency alarm signal cannot be heard over the background noise, there must be a red-flashing light or rotating beacon, in addition to the general emergency alarm signal, that:\n\n(1) Has sufficient intensity above the background lighting that would alert personnel in the space;\n\n(2) Is activated whenever the general emergency alarm signal in the space are activated; and\n\n(3) Is supplied by the general emergency alarm system power supply or the vessel emergency power source through a relay that is operated by the general emergency alarm system.\n\n(b) A red-flashing light or rotating beacon must be installed so that it is visible in the cargo pump rooms of vessels that carry combustible liquid cargoes. The installation must be in accordance with the requirements of part 111, subpart 111.105, of this chapter."], ["46:46:4.0.1.3.17.4.45.9", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.25", "Subpart 113.25\u2014General Emergency Alarm Systems", "", "\u00a7 113.25-11 Contact makers.", "USCG", "", "", "[CGD 94-108, 61 FR 28288, June 4, 1996, as amended at 62 FR 23910, May 1, 1997; USCG-2003-16630, 73 FR 65201, Oct. 31, 2008; USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "Each contact maker must\u2014\n\n(a) Have normally open contacts and be constructed in accordance with Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013 (both incorporated by reference; see \u00a7 110.10-1 of this subpart) requirements;\n\n(b) Have a switch handle that can be maintained in the \u201con\u201d position;\n\n(c) Have the \u201coff\u201d and \u201con\u201d positions of the operating handle permanently marked; and\n\n(d) Have an inductive load rating not less than the connected load or, on large vessels, have auxiliary devices to interrupt the load current."], ["46:46:4.0.1.3.17.5.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.27", "Subpart 113.27\u2014Engineers' Assistance-Needed Alarm", "", "\u00a7 113.27-1 Engineers' assistance-needed alarm.", "USCG", "", "", "", "Each self-propelled ocean, Great Lakes, or coastwise vessel must have a manually-operated engineers' assistance-needed alarm that is:\n\n(a) Operated from:\n\n(1) The engine control room, if the vessel has an engine control room; or\n\n(2) The maneuvering platform, if the vessel has no engine control room;\n\n(b) Audible in the engineers' accommodation spaces; and\n\n(c) Powered from the general alarm power source."], ["46:46:4.0.1.3.17.6.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.30", "Subpart 113.30\u2014Internal Communications", "", "\u00a7 113.30-1 Applicability.", "USCG", "", "", "", "This subpart applies to each self-propelled vessel."], ["46:46:4.0.1.3.17.6.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.30", "Subpart 113.30\u2014Internal Communications", "", "\u00a7 113.30-3 Means of communications.", "USCG", "", "", "[CGD 94-108, 61 FR 28289, June 4, 1996, as amended by USCG-2003-16630, 73 FR 65201, Oct. 31, 2008]", "(a) An emergency means of communication required by this subpart must\u2014\n\n(1) Be comprised of either fixed or portable equipment; and\n\n(2) Provide common talking means of two-way voice communication and calling among the navigating bridge, emergency control stations, muster stations, embarkation stations, and other strategic positions listed in \u00a7 113.30-5.\n\n(b) The means of communication and calling must be a reliable means of voice communication and must be independent of the vessel's electrical system."], ["46:46:4.0.1.3.17.6.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.30", "Subpart 113.30\u2014Internal Communications", "", "\u00a7 113.30-5 Requirements.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28289, June 4, 1996; 62 FR 23910, May 1, 1997; USCG-2004-18884, 69 FR 58348, Sept. 30, 2004]", "(a)  Communication.  Each vessel must have a means of communication among the following:\n\n(1) Navigating bridge.\n\n(2) Steering gear room, if outside the engineroom.\n\n(3) Alternative steering station if outside of the steering gear room.\n\n(4) Engine control room, if the vessel has an engine control room.\n\n(5) Maneuvering platform, if the vessel has no engine control room.\n\n(6) Control room, if the vessel is a mobile offshore drilling unit.\n\n(7) The engineering officers' accommodations, if the vessel is an automated, self-propelled vessel under \u00a7 62.50-20(f) of this chapter.\n\n(b)  Gyrocompass.  Each vessel that has a master gyrocompass that is not in or next to the navigating bridge must have a means of communication between the master gyrocompass and the navigating bridge repeater compass.\n\n(c)  Radar.  Each vessel that has a radar plan position indicator that is not in or next to the navigating bridge must have a means of communication between the navigating bridge and the radar plan position indicator.\n\n(d)  Emergency lockers.  If the emergency equipment lockers or spaces used by the emergency squad are not next to the navigating bridge or, on a mobile offshore drilling unit, next to the control room, there must be a means of communication between the navigating bridge or control room and the emergency equipment lockers or spaces.\n\n(e)  Radio and radio direction finder.  Communication to the radio and radio direction finder must meet the following requirements:\n\n(1) Each vessel that has a radio installation must have a means of communication between the radio room, the navigating bridge, or, if the vessel is a mobile offshore drilling unit, the control room, and any other place from which the vessel may be navigated under normal conditions, other than a place that is only for emergency functions, a place that is only for docking or maneuvering, or a place that is for navigating the vessel in close quarters. A location that has the apparatus that is necessary to steer the vessel, give engine orders, and control the whistle, is a place from which the vessel may be navigated.\n\n(2) If the operating position of the emergency radio installation is not in the compartment normally used for operating the main radio installation, there must be means of communication between the emergency radio room, the navigating bridge, or, if the vessel is a mobile offshore drilling unit, the control room, and any other place from which the vessel may be navigated under normal conditions; other than a place that is only for emergency functions, a place that is only for docking or maneuvering, or a place that is for navigating the vessel in close quarters.\n\n(3) Each vessel equipped with radio direction-finding apparatus that is not in or next to the navigating bridge must have a means of communication between the navigating bridge and the direction-finding apparatus.\n\n(4) The communication system required by this paragraph must be independent of all other systems on the vessel. The location of the termination of these systems is subject to approval by the Federal Communication Commission.\n\n(f)  Fire or smoke detecting systems.  Each vessel equipped with a fire or smoke detecting system, if control units are not in the navigating bridge, must have means of communication between the navigating bridge and the stations where the control units are located.\n\n(g)  Lookout.  Each vessel must have a means of communication between the navigating bridge and the bow or forward lookout station unless direct voice communication is possible.\n\n(h)  Engineroom local control station.  Each self-propelled vessel equipped with control from the navigating bridge must have a means of communication between the local station for the control of the speed or direction of thrust of the propulsion machinery and the engine control room, unless an engine order telegraph is installed in accordance with \u00a7 113.35-3. Each communication station at a local control station must\u2014\n\n(1) Be on a circuit separate from any other station required by this section; and\n\n(2) Provide the capability of reliable voice communication when the vessel is underway.\n\n(i)  Mobile offshore drilling units.  Each non-self-propelled mobile offshore drilling unit must have a means of communication among the control room, drill floor, machinery space, and silicon controlled rectifier (SCR) room (if installed). Each column-stabilized mobile offshore drilling unit must have a means of communication between the ballast control room and the spaces that contain the ballast pumps and valves."], ["46:46:4.0.1.3.17.6.45.4", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.30", "Subpart 113.30\u2014Internal Communications", "", "\u00a7 113.30-20 General requirements.", "USCG", "", "", "[CGD 94-108, 61 FR 28289, June 4, 1996, as amended by USCG-2003-16630, 73 FR 65201, Oct. 31, 2008]", "(a) The communications stations listed in \u00a7 113.30-5(a) through (d), (f), (g), and (i) and other communications stations for the operation of the vessel, such as the captain's and chief engineer's offices and staterooms, emergency power room, carbon dioxide (or other extinguishing agent) control room, and firepump room, must not be on the same circuit as communications stations installed to meet the requirements of \u00a7\u00a7 113.30-5(e) and 113.30-5(h).\n\n(b) If a communications station is in the weather and on the same circuit as other required stations, there must be a cut-out switch on the navigating bridge that can isolate this station from the rest of the stations, unless the system possesses other effective means of station isolation during a fault condition.\n\n(c) No jack-box or headset may be on a communication system that includes any station required by this subpart, except for a station installed to meet 46 CFR 113.30-5(h) or 46 CFR 113.30-25(f)."], ["46:46:4.0.1.3.17.6.45.5", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.30", "Subpart 113.30\u2014Internal Communications", "", "\u00a7 113.30-25 Detailed requirements.", "USCG", "", "", "[USCG-2003-16630, 73 FR 65201, Oct. 31, 2008; USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "(a) Multiple stations must be able to communicate at the same time.\n\n(b) The loss of one component of the system must not disable the rest of the system.\n\n(c) The system must be able to operate under full load for the same period of operation as required for the emergency generator. See 46 CFR 112.05-5, Table 112.05-5(a).\n\n(d) Each voice-communication station device in the weather must be in a proper enclosure as required in 46 CFR 111.01-9. The audible-signal device must be outside the station enclosure.\n\n(e) Each station in a navigating bridge or a machinery space must be in an enclosure meeting at least Type 2 of NEMA 250 or IP 22 of IEC 60529:2013 (both incorporated by reference; see \u00a7 110.10-1 of this subpart).\n\n(f) In a noisy location, such as an engine room, there must be a booth or other equipment to permit reliable voice communication while the vessel is operating.\n\n(g) In a space throughout which the voice communication station audible-signal device cannot be heard, there must be another audible-signal device or a visual-device, such as a light, either of which is energized from the final emergency bus.\n\n(h) If two or more voice communication stations are near each other, there must be a means that indicates the station called.\n\n(i) Each connection box must meet at least Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013.\n\n(j) Voice communication cables must run as close to the fore-and-aft centerline of the vessel as practicable.\n\n(1) No cable for voice communication may run through any space at high risk of fire such as machinery rooms and galleys, unless it is technically impracticable to route it otherwise or it must serve circuits within those spaces.\n\n(2) Each cable running through any space at high risk of fire must meet 60331-11:2009 and 60331-21:1999 (both incorporated by reference; see \u00a7 110.10-1 of this subpart).\n\n(k) If the communications system uses a sound-powered telephone, the following requirements also apply:\n\n(1) Each station except one regulated by paragraph (d) of this section must include a permanently wired handset with a push-to-talk button and a hanger for the handset.\n\n(2) The hanger must be constructed so that it holds the handset away from the bulkhead and so that the motion of the vessel will not dislodge the handset.\n\n(3) Each talking circuit must be electrically independent of each calling circuit.\n\n(4) No short circuit, open circuit, or ground on either side of a calling circuit may affect a talking circuit.\n\n(5) Each circuit must be insulated from ground."], ["46:46:4.0.1.3.17.7.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-1 Definitions.", "USCG", "", "", "", "As used in this subpart:\n\n(a)  Indicator  means an instrument in the engine room to receive and acknowledge engine orders; and\n\n(b)  Transmitter  means an instrument to send engine orders to the engineroom and receive acknowledgement from the engineroom."], ["46:46:4.0.1.3.17.7.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-3 General requirements.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 81-030, 53 FR 17847, May 18, 1988; CGD 94-108, 61 FR 28290, June 4, 1996]", "(a) Each self-propelled vessel, except as provided in paragraph (d) of this section, must have an electric or mechanical engine order telegraph system from the navigating bridge to the engineroom.\n\n(b) On a vessel with more than one propulsion engine, each engine must have this system.\n\n(c) On a double-ended vessel that has two navigating bridges, this system must be between the engineroom and each navigating bridge.\n\n(d) If a small vessel has no engine order telegraph system between the navigating bridge and the engineroom, the propulsion plant must be controlled entirely from the navigating bridge, with no means of normal engine control from the engineroom.\n\n(e) On vessels equipped with pilothouse control, each local control station in the engineroom must have an indicator if:\n\n(1) Manual operation from the local control station is an alternative means of control; and\n\n(2) The local control station is not immediately adjacent to the engineroom control station; and\n\n(3) Reliable voice communication and calling that meets the requirements of \u00a7 113.30-5(h) is not provided.\n\n(f) Engine order telegraph and remote propulsion control systems must be electrically separate and independent, except that a single mechanical operator control device with separate transmitters and connections for each system may be used."], ["46:46:4.0.1.3.17.7.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-5 Electric engine order telegraph systems.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28290, June 4, 1996]", "(a) Each electric engine order telegraph system must have transmitters and indicators that are electrically connected to each other.\n\n(b) Each engineroom indicator must be capable of acknowledgment of orders.\n\n(c) There must be an audible signal at each instrument. The signal at both locations must sound continuously when the transmitter and the indicator do not show the same order.\n\n(d) Each telegraph instrument must meet the protection requirements of \u00a7 111.01-9 of this chapter.\n\n(e) Each system must have an alarm which\u2014\n\n(1) Automatically sounds and visually signals a loss of power to the system;\n\n(2) Is on the navigating bridge; and\n\n(3) Has a means to reduce the audible signal from 100 percent to not less than 50 percent."], ["46:46:4.0.1.3.17.7.45.4", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-7 Electric engine order telegraph systems; operations.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982. Redesignated and amended by CGD 94-108, 61 FR 28290, June 4, 1996]", "(a) Where two or more transmitters, located on or on top of, or on the wings of, the navigating bridge operate a common indicator in the engineroom, the transmitters must:\n\n(1) Operate in synchronism as required in paragraph (b) of this section; or\n\n(2) Operate under the control of a transmitter transfer control in accordance with paragraph (c) of this section.\n\n(b) All transmitter handles and pointers must operate in synchronism. Where the transmitters are mechanically interlocked to effect synchronous operation, the requirements of \u00a7 113.35-13 must be met.\n\n(c) Except for a transmitter in an unattended navigating bridge on a double-ended vessel, each transmitter must operate under the control of a transmitter transfer control so that movement of any one transmitter handle automatically connects that transmitter electrically to the engineroom indicator and simultaneously disconnects electrically all other transmitters. The reply pointers of all transmitters must operate in synchronism at all times.\n\n(d) On a double-ended vessel that has two navigating bridges, a manually operated transfer switch which will disconnect the system in the unattended navigating bridge must be provided."], ["46:46:4.0.1.3.17.7.45.5", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-9 Mechanical engine order telegraph systems.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28290, June 4, 1996]", "(a) Each mechanical engine order telegraph system must consist of transmitters and indicators mechanically connected to each other, as by means of chains and wires.\n\n(b) Each transmitter and each indicator must have an audible signal device to indicate, in the case of an indicator, the receipt of an order, and in the case of a transmitter, the acknowledgment of an order. The audible signal device must not be dependent upon any source of power for operation other than that of the movement of the transmitter or indicator handle."], ["46:46:4.0.1.3.17.7.45.6", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-13 Mechanical engine order telegraph systems; operation.", "USCG", "", "", "", "If more than one transmitter operates a common indicator in the engineroom, all the transmitters must be mechanically interlocked and operate in synchronism. A failure of the transmission wire or chain at any transmitter must not interrupt or disable any other transmitter."], ["46:46:4.0.1.3.17.7.45.7", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-15 Mechanical engine order telegraph systems; application.", "USCG", "", "", "", "If a mechanical engine order telegraph system is installed on any vessel to provide the communication required by this subpart, the length of cables or other mechanical limitations must not prevent the efficient operation of the system."], ["46:46:4.0.1.3.17.7.45.8", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.35", "Subpart 113.35\u2014Engine Order Telegraph Systems", "", "\u00a7 113.35-17 Vessels with navigating bridge control.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28290, June 4, 1996]", "Each vessel with navigating bridge throttle control must have a positive mechanical stop on each telegraph transmitter that prevents movement to the \u201cNavigating Bridge Control\u201d position without positive action by the operator."], ["46:46:4.0.1.3.17.8.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.37", "Subpart 113.37\u2014Shaft Speed and Thrust Indicators", "", "\u00a7 113.37-1 Applicability.", "USCG", "", "", "", "This subpart applies to all self-propelled vessels."], ["46:46:4.0.1.3.17.8.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.37", "Subpart 113.37\u2014Shaft Speed and Thrust Indicators", "", "\u00a7 113.37-5 General requirements.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28290, June 4, 1996]", "(a) A vessel equipped with fixed pitch propellers must have on the navigating bridge and at the engineroom control station a propeller speed and direction indicator for each shaft.\n\n(b) A vessel equipped with controllable pitch propellers must have on the navigating bridge and at the engineroom control station a propeller speed and pitch position indicator for each shaft."], ["46:46:4.0.1.3.17.8.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.37", "Subpart 113.37\u2014Shaft Speed and Thrust Indicators", "", "\u00a7 113.37-10 Detailed requirements.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28290, June 4, 1996; USCG-2003-16630, 73 FR 65202, Oct. 31, 2008; USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "(a) Each indicator must be independent of the propulsion control system. A failure of the propulsion control system must not affect the operation of the indicators.\n\n(b) Each electric component or its enclosure must meet Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013 (both incorporated by reference; see \u00a7 110.10-1 of this subpart) requirements."], ["46:46:4.0.1.3.17.9.45.1", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.40", "Subpart 113.40\u2014Rudder Angle Indicator Systems", "", "\u00a7 113.40-1 Applicability.", "USCG", "", "", "", "This subpart applies to self-propelled vessels."], ["46:46:4.0.1.3.17.9.45.2", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.40", "Subpart 113.40\u2014Rudder Angle Indicator Systems", "", "\u00a7 113.40-5 General requirements.", "USCG", "", "", "", "The position of the rudder, if power-operated, must be shown at the principal steering station. If there is non-follow-up steering control at the alternative steering station, there must be a separate rudder angle indicator system for that station that is electrically independent from each other rudder angle indicator system."], ["46:46:4.0.1.3.17.9.45.3", 46, "Shipping", "I", "J", "113", "PART 113\u2014COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT", "113.40", "Subpart 113.40\u2014Rudder Angle Indicator Systems", "", "\u00a7 113.40-10 Detailed requirements.", "USCG", "", "", "[CGD 74-125A, 47 FR 15272, Apr. 8, 1982, as amended by CGD 94-108, 61 FR 28290, June 4, 1996; 62 FR 23910, May 1, 1997; USCG-2003-16630, 73 FR 65202, Oct. 31, 2008; USCG-2020-0075, 88 FR 16369, Mar. 16, 2023]", "(a) Each rudder angle indicator system must have a transmitter at the rudder head that is actuated by movement of the rudder with the angular movements of the rudder transmitted to a remote indicator or indicators. This system must be independent of all other systems and not receive power or signal from the steering gear control, autopilot, or dynamic positioning systems. However, the indicator may be physically located on a control console, such as an integrated bridge system, if it is readily visible by the helmsman at the steering stand.\n\n(b) Each electric component or its enclosure must meet Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013 (both incorporated by reference; see \u00a7 110.10-1 of this subpart) requirements."], ["9:9:1.0.1.5.51.0.74.1", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.1 Compliance.", "APHIS", "", "", "", "The regulations in this part apply to each serial or subserial of a licensed biological product manufactured in a licensed establishment and to each serial or subserial of a biological product in each shipment imported for distribution and sale."], ["9:9:1.0.1.5.51.0.74.10", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.10 Testing of bulk material for export or for further manufacture.", "APHIS", "", "", "[49 FR 45846, Nov. 21, 1984]", "When a product is prepared in a licensed establishment for export in large multiple-dose containers as provided in \u00a7 112.8(d) or (e) of this subchapter or for further manufacturing purposes as provided in \u00a7 114.3(d) of this subchapter, samples of the bulk material shall be subjected to all required tests prescribed in the filed Outline of Production or Standard Requirements for the product. Samples of concentrated liquid product shall be diluted to a volume equal to the contents of the sample times the concentration factor prior to initiating potency tests."], ["9:9:1.0.1.5.51.0.74.2", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.2 Testing aids.", "APHIS", "", "", "[39 FR 21041, June 18, 1974, as amended at 40 FR 758, Jan. 3, 1975; 50 FR 21799, May 29, 1985; 56 FR 66784, Dec. 26, 1991]", "To better ensure consistent and reproducible test results when Standard Requirement tests prescribed in the regulations are conducted, National Veterinary Services Laboratories, U.S. Department of Agriculture, may provide testing aids, when available, to licensees, permittees, and applicants for licenses and permits. Such aids shall be as follows:\n\n(a) Supplemental Assay Method (SAM) is a technical bulletin containing detailed instructions for conducting a test. Such instructions shall be in accordance with the procedures currently being followed at National Veterinary Services Laboratories and as improved, proven procedures are developed, shall be revised and reissued prior to application.\n\n(b) Standard Reference Preparation is a serum, virus, bacterial culture, or antigen to be used in test systems for direct comparison with serials of biological products under test.\n\n(c) Standard Test Reagent is a serum, antitoxin, fluorescent antibody conjugate, toxin, virus, bacterial cultural, or antigen to be used in test systems but not for direct comparison with serials of biological products under test.\n\n(d) Seed cultures are small quantities of standard organisms to be propagated by the recipient to establish a supply for use.\n\n(e) Test Code Number is a number assigned by Animal and Plant Health Inspection Service to each test procedure specified in the Standard Requirements and in each filed Outline of Production where such test is conducted to support a request for release of a serial or subserial."], ["9:9:1.0.1.5.51.0.74.3", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.3 Sampling of biological products.", "APHIS", "", "", "[38 FR 29886, Oct. 30, 1973, as amended at 40 FR 758, Jan. 3, 1975; 40 FR 49768, Oct. 24, 1975; 41 FR 56627, Dec. 29, 1976; 48 FR 9506, Mar. 7, 1983; 48 FR 57473, Dec. 30, 1983; 50 FR 21799, May 29, 1985; 56 FR 66784, Dec. 26, 1991; 60 FR 14356, Mar. 17, 1995; 67 FR 15713, Apr. 3, 2002]", "Each licensee and permittee shall furnish representative samples of each serial or subserial of a biological product manufactured in the United States or imported into the United States as prescribed in this section. Additional samples may be purchased in the open market by a Animal and Plant Health Inspection Service representative.\n\n(a) Either an employee of the Department of Agriculture, of the licensee, or of the permittee, as designated by the Administrator shall select prerelease samples of biological product in the number prescribed in paragraph (b) of this section. Each sample shall be marked for identification by the person making the selection after which they shall be packaged by the licensee or permittee, as the case may be, and forwarded to National Veterinary Services Laboratories; except that an employee of the Department may forward or deliver the samples to National Veterinary Services Laboratories if such action deemed advisable by the Administrator.\n\n(1) Selection shall be made as follows:\n\n(i) Nonviable liquid biological products\u2014either bulk or final container samples of completed product shall be selected for purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi.\n\n(ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the end of the filling operation. Bulk containers of completed product may be sampled when authorized by the Administrator.\n\n(iii) Desiccated biological products; samples shall be in final containers and shall be randomly selected if desiccated in the final container. Biological products desiccated in bulk shall be sampled at the end of the filling operation.\n\n(iv) Representative samples of each serial or subserial in each shipment of imported biological products shall be selected.\n\n(2) Comparable samples shall be used by Animal and Plant Health Inspection Service, the licensee, and the permittee for similar tests.\n\n(3) When bulk samples of completed product in liquid form are to be tested as prescribed in paragraph (a)(1) of this section, the number of such samples from each serial and the minimum quantity of product to be provided in each sample shall be stated in the filed Outline of Production.\n\n(b) Unless otherwise prescribed by the Administrator, the number of final container samples to be selected from each serial and subserial shall be:\n\n(1)  Vaccines:\n\n(i) Six multiple-dose samples of Brucella Abortus Vaccine;\n\n(ii) Twelve samples of all other live bacterial vaccines;\n\n(iii) Two samples of Coccidiosis Vaccine;\n\n(iv) Eighteen samples of Rabies Vaccine, Modified Live Virus;\n\n(v) Sixteen samples of all other vaccines consisting of live microorganisms;\n\n(vi) Thirty single-dose or 14 multiple-dose samples of Equine Encephalomyelitis Vaccine, Killed Virus;\n\n(vii) Twenty-two single-dose or 14 multiple-dose samples of Rabies Vaccine, Killed Virus;\n\n(viii) Sixteen single-dose or 12 multiple-dose samples of all other vaccines consisting of killed microorganisms.\n\n(2)  Bacterins and bacterin-toxoids:\n\n(i) Twelve samples of single-fraction products;\n\n(ii) Thirteen samples of two-fraction products;\n\n(iii) Fourteen samples of products consisting of 3 or more fractions.\n\n(3)  Antiserums:  Twelve samples of antiserum recommended for large animals or 14 samples of antiserum recommended for small animals or the number of reagent serum samples prescribed in the filed Outline of Production for the product.\n\n(4)  Antitoxins:\n\n(i) Fourteen single-dose or 12 multiple dose samples of Tetanus Antitoxin;\n\n(ii) Twelve samples of all other antitoxins.\n\n(5)  Toxoids:\n\n(i) Eighteen single-dose or 12 multiple dose samples of all toxoids.\n\n(6)  Antigens:  Twelve samples of poultry antigens or 20 samples of tuberculin or four samples of all other diagnostic antigens.\n\n(7)  Diagnostic test kits:  Two samples of diagnostic test kits. The licensee or permittee will hold one of these selected samples at the storage temperature recommended on the label while awaiting a request by the animal and Plant Health Inspection Service to submit the additional sample. If submission is not requested by the Animal and Plant Health Inspection Service, the additional sample may be returned to the serial inventory after the serial is released. In the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, the licensee or permittee may submit a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production and retain a similar amount as a second sample for submission upon request. When the initial sample is not representative of final packaging by the licensee of permittee, e.g., does not consist of all the microtiter test plates or strips, the second sample is not eligible to be returned to serial inventory after the serial is released.\n\n(8)  Autogenous biologics:  With the exception of the first serial or subserial, 10 samples must be selected and submitted to the Animal and Plant Health Inspection Service from each serial or subserial of an autogenous biologic eligible to be shipped that consists of more than 50 containers. For first serials or subserials eligible for shipment consisting of more than 50 containers, 10 samples from each serial or subserial must be selected and held for submission to the Animal and Plant Health Inspection Service upon request in accordance with paragraph (e)(4) of this section. For serials or subserials of autogenous biologic with 50 or fewer containers, no samples, other than those required by paragraph (e) of this section, are required.\n\n(9)  Miscellaneous:  The number of samples from products not in the categories provided for in paragraphs (b)(1) through (b)(8) of this section shall be prescribed in the filed Outline of Production for the product.\n\n(c) Prelicensing and Outline of Production changes: Samples needed to support a license application or a change in the Outline of Production for a licensed product shall be submitted only upon request from the animal and Plant Health Inspection Service. Except for miscellaneous products specified in paragraph (b)(9) of this section, the number of such samples shall be at least one and one-half times the number prescribed for such product in paragraph (b) of this section. Samples of Master Seeds and Master Cell Stocks with a minimum individual volume of 1 ml shall be submitted as follows:\n\n(1) Ten samples of Bacterial Master Seeds.\n\n(2) Thirteen samples of viral Master Seeds or nonviral Master Seeds requiring cell culture propagation. For Master Seeds isolated or passed in a cell line different from the species of intended use, an additional 2 samples are required for each additional species. For Master Seeds grown in cell culture and intended for use in more than one species, an additional 2 samples are required for each additional species.\n\n(3) Thirty-six samples of at least 1 ml each or six samples of at least 1 ml each, one sample of at least 20 ml, and one sample of at least 10 ml of Master Cell Stocks. In the case of Master Cell Stocks which are persistently infected with a virus, an additional four samples of at least 1 ml each are required. If these persistently infected cell stocks are intended for use in more than one species, an additional two samples of at least 1 ml each are required for each additional species.\n\n(4) Four samples of the Master Cell Stock + n (highest passage) cells.\n\n(d) Sterile diluent: A sample of Sterile Diluent shall accompany each sample of product, other than Marek's Disease Vaccine, if such diluent is required to rehydrate or dilute the product before use. The volume of diluent shall be an appropriate amount to rehydrate or dilute the product. Samples of Sterile Diluent prepared for use with Marek's Disease Vaccine shall be submitted upon request from the Animal and Plant Health Inspection Service.\n\n(e) Reserve samples shall be selected from each serial and subserial of biological product. Such samples shall be selected at random from final containers of completed product by an employee of the Department, of the licensee, or of the permittee, as designated by the administrator. Each sample shall:\n\n(1) Consist of 5 single-dose packages, 2 multiple-dose packages, or 2 diagnostic test kits, except that, in the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, a sample may consist of a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production;\n\n(2) Be adequate in quantity for appropriate examination and testing;\n\n(3) Be truly representative and in final containers;\n\n(4) Be held in a special compartment set aside by the licensee or permittee for holding these samples under refrigeration at the storage temperature recommended on the labels for 6 months after the expiration date stated on the labels. The samples that are stored in this manner shall be delivered to the Animal and Plant Health Inspection Service upon request."], ["9:9:1.0.1.5.51.0.74.4", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.4 Exemptions to tests.", "APHIS", "", "", "[38 FR 29887, Oct. 30, 1973, as amended at 56 FR 66784, Dec. 26, 1991]", "(a) The test methods and procedures contained in all applicable Standard Requirements shall be complied with unless otherwise exempted by the Administrator and provided that such exemption is noted in the filed Outline of Production for the product.\n\n(b) Test methods and procedures by which the biological products shall be evaluated shall be designated in the Outline of Production for such products."], ["9:9:1.0.1.5.51.0.74.5", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.5 General testing.", "APHIS", "", "", "[34 FR 18004, Nov. 4, 1969, as amended at 39 FR 25463, July 11, 1974; 40 FR 45420, Oct. 2, 1975; 40 FR 46093, Oct. 6, 1975; 41 FR 6751, Feb. 13, 1976; 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 79 FR 55969, Sept. 18, 2014]", "(a) No biological product shall be released prior to the completion of tests prescribed in a filed Outline of Production or Standard Requirements for the product to establish the product to be pure, safe, potent, and efficacious.\n\n(b) Tests of biological products shall be observed by a competent employee of the manufacturer during all critical periods. A critical period shall be the time when certain specified reactions must occur in required tests to properly evaluate the results.\n\n(c) Records of all tests shall be kept in accordance with part 116 of this chapter. Results of all required tests prescribed in the filed Outline of Production or the Standard Requirements for the product shall be submitted to Animal and Plant Health Inspection Service. Blank forms shall be furnished upon request to Animal and Plant Health Inspection Service.\n\n(d) When the initial or any subsequent test is declared a No Test, the reasons shall be reported in the test records, the results shall not be considered as final, and the test may be repeated. When a test is declared satisfactory, the test designation is considered to be a final conclusion. When a test is declared unsatisfactory, the test designation is considered to be a final conclusion. When the initial or any subsequent test is declared inconclusive, the reasons shall be reported in the test records, the result shall not be considered as final, and the test may be repeated as established in the filed Outline of Production or Standard Requirement. If a test is designated inconclusive or No Test and the biological product is not further tested, the test designation of unsatisfactory is the final conclusion.\n\n(e) When new test methods are developed and approved by Animal and Plant Health Inspection Service, biological products tested thereafter shall be evaluated by such methods, and if not found to be satisfactory when so tested shall not be released."], ["9:9:1.0.1.5.51.0.74.6", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.6 Animal and Plant Health Inspection Service testing.", "APHIS", "", "", "[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 45420, Oct. 2, 1975; 40 FR 53378, Nov. 18, 1975; 41 FR 6751, Feb. 13, 1976; 56 FR 66784, Dec. 26, 1991]", "A biological product shall with reasonable certainty yield the results intended when used as recommended or suggested in its labeling or proposed labeling prior to the expiration date.\n\n(a) The Administrator is authorized to cause a biological product, manufactured in the United States or imported into the United States, to be examined and tested for purity, safety, potency, or efficacy; in which case, the licensee or permittee shall withhold such product from the market until a determination has been made.\n\n(b) The final results of each test conducted by the licensee and Animal and Plant Health Inspection Service shall be considered in evaluating a biological product. A serial or subserial which has been found unsatisfactory by a required test prescribed in a filed Outline of Production or Standard Requirement is not in compliance with the regulations and shall not be released for market."], ["9:9:1.0.1.5.51.0.74.7", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.7 Multiple fractions.", "APHIS", "", "", "[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 46093, Oct. 6, 1975; 56 FR 66785, Dec. 26, 1991]", "(a) When a biological product contains more than one immunogenic fraction, the completed product shall be evaluated by tests applicable to each fraction.\n\n(b) When similar potency tests are required for more than one fraction of a combination biological product, different animals must be used to evaluate each fraction except when written Standard Requirements or outlines of production make provisions and set forth conditions for use of the same animals for testing different fractions.\n\n(c) When the same safety test is required for more than one fraction, requirements are fulfilled by satisfactory results from one test of the completed product.\n\n(d) When an inactivated fraction(s) is used as a diluent for a live virus fraction(s), the inactivated fraction(s) may be tested separately and the live virus fraction(s) may be tested separately:  Provided,  That, the viricidal test requirements prescribed in \u00a7 113.100 are complied with.\n\n(e) Virus titrations for a multivirus product shall be conducted by methods which will quantitate each virus."], ["9:9:1.0.1.5.51.0.74.8", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.8 In vitro tests for serial release.", "APHIS", "", "", "[49 FR 22625, May 31, 1984, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 62 FR 19038, Apr. 18, 1997; 72 FR 72564, Dec. 21, 2007; 79 FR 31021, May 30, 2014]", "(a) Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seed for production as specified in the Standard Requirements or in the filed Outline of Production. The Administrator may exempt a product from a required animal potency test for release when an evaluation can, with reasonable certainty, be made by:\n\n(1) Subjecting the master seed to the applicable requirements prescribed in \u00a7\u00a7 113.64, 113.100, 113.200, and 113.300;\n\n(2) Testing the Master Seed for immunogenicity in a manner acceptable to the Animal and Plant Health Inspection Service (APHIS);\n\n(3) Establishing satisfactory potency for the product in accordance with the following provisions:\n\n(i) Potency for live products may be determined by log 10  virus titer or determining the live bacterial count based on the protective dose used in the Master Seed immunogenicity test plus an adequate overage for adverse conditions and test error; and\n\n(ii) Potency for inactivated products may be determined using tests for relative antigen content by comparing the antigen content of the test serial to a reference preparation using a parallel line immunoassay or equivalent method which measures linearity, specificity, and reproducibility in a manner acceptable to APHIS.\n\n(b) In the case of live products, each serial and subserial of desiccated product derived from an approved Master Seed and bulk or final container samples of each serial of completed liquid product derived from an approved Master Seed shall be evaluated by a test procedure acceptable to APHIS. On the basis of the results of the test, as compared with the required minimum potency, each serial and subserial shall either be released to the firm for marketing or withheld from the market. The evaluation of such products shall be made in accordance with the following criteria:\n\n(1) If the initial test shows the count or titer to equal or exceed the required minimum, the serial or subserial is satisfactory without additional testing.\n\n(2) If the initial test shows the count or titer to be lower than the required minimum, the serial or subserial may be retested, using double the number of samples. The average counts or titers obtained in the retests shall be determined. If the average is less than the required minimum, the serial or subserial is unsatisfactory without further consideration.\n\n(3) If the average is equal to or greater than the required minimum, the following shall apply to live virus vaccines:\n\n(i) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is 10 \n 0.7  or greater, the initial titer may be considered a result of test system error and the serial or subserial considered satisfactory for virus titer.\n\n(ii) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is less than 10 \n 0.7 , a new average shall be determined using the titers obtained in all tests. If the new average is below the required minimum, the serial or subserial is unsatisfactory.\n\n(4) If the average is equal to or greater than the required minimum, the following shall apply to bacterial vaccines:\n\n(i) If the average count obtained in the retests is at least three times the count obtained in the initial test, the initial count may be considered a result of test system error and the serial or subserial considered satisfactory for bacterial count.\n\n(ii) If the average count obtained in the retests is less than three times the count obtained in the initial test, a new average shall be determined using the counts obtained in all tests. If the new average count is below the required minimum, the serial or subserial is unsatisfactory.\n\n(5)  Exceptions.  When a product is evaluated in terms other than log 10  virus titer or organism count, an appropriate difference between the average potency value obtained in the retests and the potency value obtained in the initial test shall be established for use in paragraphs (b)(3) and (b)(4) of this section to evaluate such products and shall be specified in the product Standard Requirement or filed Outline of Production.\n\n(c) In the case of inactivated products, bulk or final container samples of completed product from each serial derived from an approved Master Seed, shall be evaluated for relative antigen content (potency) as compared with an unexpired reference by a parallel line immunoassay or other procedure acceptable to APHIS. Firms currently using immunoassays which do not satisfy this requirement shall have 2 years from the effective date of the final rule to update their filed Outlines of Production to be in compliance with this requirement unless granted an extension by the Administrator based on a showing by the firm seeking the extension that they have made a good faith effort with due diligence to achieve compliance. On the basis of the results of such test procedures, each serial that meets the required minimum potency shall be released to the firm for marketing; each serial not meeting the required minimum potency shall be withheld from the market. The evaluation of such products shall be made in accordance with the following criteria:\n\n(1) A test that results in no valid lines is considered a \u201cno test\u201d and may be repeated.\n\n(2) An initial test (test 1) that results in valid lines that are not parallel is considered a valid equivocal test. Release of the serial may not be based on such test since the result cannot be termed \u201csatisfactory\u201d or \u201cunsatisfactory.\u201d\n\n(3) If the initial test (test 1) shows that potency equals or exceeds the required minimum potency, the serial is satisfactory without additional testing.\n\n(4) If the initial test (test 1) is an equivocal test due to lack of parallelism, the serial may be retested up to three times (tests 2, 3, and 4) with disposition to be as specified in paragraphs (c)(4)(i) and (ii) of this section;  Provided,  That, if the serial is not retested or the other provisions of this section are not satisfied, the serial shall be deemed unsatisfactory.\n\n(i) If: The first retest (test 2) following an initial equivocal test; the second retest (test 3) following two consecutive equivocal tests (tests 1 and 2); or the third retest (test 4) following three consecutive equivocal tests (tests 1, 2, and 3) shows that the potency equals or exceeds the required minimum potency, the serial is satisfactory.\n\n(ii) If the first retest (test 2) following an initial equivocal test shows that potency is less than the required minimum potency, disposition of the serial will be based on the outcome of retests 2 and 3 (tests 3 and 4) as follows: if either retest (test 3 or 4) shows that potency is less than the required minimum potency, the serial is unsatisfactory. If either retest 2 or retest 3 (tests 3 or 4) is an equivocal test, or in the event that each retest (tests 2, 3, and 4) following an initial equivocal test is also an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld. In which case, the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to APHIS, the potency test may be repeated by the firm, subject to the provisions specified in paragraphs (i) and (ii) and confirmatory testing by APHIS.\n\n(5) If the initial test (test 1) shows that potency is less than the required minimum potency, the serial may be retested a minimum of two times (tests 2 and 3) but not more than three times (tests 2, 3, and 4) with disposition as specified in paragraphs (c)(5) (i) and (ii) of this section;  Provided,  That, if the serial is not retested or the other provisions of this section are not satisfied, the serial shall be deemed unsatisfactory.\n\n(i) If two consecutive retests (tests 2 and 3) show that potency of the serial equals or exceeds the required minimum potency, the serial is satisfactory. If one of the two retests (test 2 or 3) shows that the potency is less than the required minimum potency, the serial is unsatisfactory.\n\n(ii) If one of the retests (tests 2 or 3) shows that the potency equals or exceeds the required minimum potency and the other retest (test 2 or 3) is an equivocal test, a third retest (test 4) may be performed. If the third retest (test 4) shows that the potency of the serial equals or exceeds the required minimum potency, the serial is deemed satisfactory. If both retests (tests 2 and 3) or if the third retest (test 4) is an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld, in which case the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to APHIS, the potency test may be repeated by the firm, subject to the provisions specified in paragraphs (c)(4) (i) and (ii) and (c)(5) (i) and (ii) of this section, and confirmatory testing by APHIS.\n\n(d)  Extending the dating of a reference.  All determinations of relative antigen content using parallel line immunoassays or equivalent methods shall be conducted with an unexpired reference. The lot of reference used to determine antigenic content shall have an initial dating period equal to the dating of the product or as supported by data acceptable to APHIS, except that frozen references may have an initial dating of up to 5 years,  Provided,  That the request for dating of the frozen references beyond the dating of the product is supported by preliminary data acceptable to APHIS and includes provisions for monitoring the stability of the reference to determine when the potency starts to decline and for taking the appropriate steps to requalify a reference with declining potency either by testing a Qualifying Serial in host animals or by providing other evidence of immunogenicity, e.g., antibody titers or laboratory animal test data previously correlated to host animal protection in a manner acceptable to APHIS. Prior to the expiration date, such reference may be granted an extension of dating,  Provided,  That its immunogenicity has been confirmed using a Qualifying Serial of product in a manner acceptable to APHIS. The dating period of the Master Reference and Working Reference may be extended by data acceptable to APHIS if the minimum potency of the Master Reference is determined to be adequately above the minimum level needed to provide protection in the host animal. If a new Master Reference is established, it shall be allowed an initial dating period equal to the dating of the product or as supported by data acceptable to APHIS, except that frozen references may have an initial dating period of 5 years, or as supported by data acceptable to APHIS. Prior to the expiration date, such reference may be granted an extension of dating by confirming its immunogenicity using a Qualifying Serial of product.\n\n(e) Final container samples of completed product derived from Master Seed found immunogenic in accordance with paragraph (a) of this section and found satisfactory in accordance with paragraphs (b) and (c) of this section may also be subjected to an animal potency test by Animal and Plant Health Inspection Service as provided in this paragraph. Products shall be used according to label directions including dose(s) and route of administration.\n\n(1) A one stage test using 20 vaccinates and 5 controls or a two stage test using 10 vaccinates and 5 controls for each stage shall be used. The criteria used for judging the specific response in the controls and vaccinates shall be in accordance with the test protocol used in the Master Seed immunogenicity test.\n\n(2) If at least 80 percent of the controls do not show specific responses to challenge, the test is inconclusive and may be repeated. If a vaccinate shows the specific responses to challenge expected in the controls, the vaccinate shall be listed as a failure.\n\n(3) The results of the testing shall be evaluated according to the following table:\n\nCumulative totals\n\n(4) When a serial has been found unsatisfactory for potency by the test provided in paragraphs (e)(1), (2), and (3) of this section, the serial shall be withheld from the market and the following actions taken:\n\n(i) The Administrator shall require that at least two additional serials prepared with the same Master Seed be subjected to similar animal potency tests by Animal and Plant Health Inspection Service or the licensee or both.\n\n(ii) If another serial is found unsatisfactory for potency, the product shall be removed from the market while a reevaluation of the product is made and the problem is resolved."], ["9:9:1.0.1.5.51.0.74.9", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.9 New potency test.", "APHIS", "", "", "[40 FR 14084, Mar. 28, 1975, as amended at 56 FR 66784, Dec. 26, 1991]", "A potency test written into the filed Outline of Production for a product shall be considered confidential information by Animal and Plant Health Inspection Service until at least two additional product licenses are issued for the product or unless use of the test is authorized by the licensee, in which case, such potency test may be published as part of the Standard Requirement for the product.\n\n(a) Until a potency test is published as part of the Standard Requirement for the product, reference to such a test shall be made in the filed Outline of Production and the test shall be conducted.\n\n(b) When a potency test has been published as part of the Standard Requirement, such test shall be conducted unless the product is specifically exempted as provided in \u00a7 113.4."], ["9:9:1.0.1.5.51.0.75.11", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.25 Culture media for detection of bacteria and fungi.", "APHIS", "", "", "[35 FR 16039, Oct. 13, 1970, as amended at 37 FR 2430, Feb. 1, 1972; 41 FR 27715, July 6, 1976; 56 FR 66784, Dec. 26, 1991]", "(a) Ingredients for which standards are prescribed in the United States Pharmacopeia, or elsewhere in this part, shall conform to such standards. In lieu of preparing the media from the individual ingredients, they may be made from dehydrated mixtures which, when rehydrated with purified water, have the same or equivalent composition as such media and have growth-promoting buffering, and oxygen tension-controlling properties equal to or better than such media. The formulas for the composition of the culture media prescribed in \u00a7\u00a7 113.26 and 113.27 are set forth in the United States Pharmacopeia, 19th Edition.\n\n(b) The licensee shall test each quantity of medium prepared at one time from individual ingredients and the first quantity prepared from each lot of commercial dehydrated medium for growth-promoting qualities. If any portion of a lot of commercial dehydrated medium is held for 90 days or longer after being so tested, it shall be retested before use. Two or more strains of micro-organisms that are exacting in their nutritive requirements shall be used. More than one dilution shall be used to demonstrate the adequacy of the medium to support the growth of a minimum number of micro-organisms.\n\n(c) The sterility of the medium shall be confirmed by incubating an adequate number of test vessels and examining each for growth. Additional control may be used by incubation of representative uninoculated test vessels for the required incubation period during each test.\n\n(d) A determination shall be made by the licensee for each biological product of the ratio of inoculum to medium which shall result in sufficient dilution of such product to prevent bacteriostatic and fungistatic activity. The determination may be made by tests on a representative biological product for each group of comparable products containing identical preservatives at equal or lower concentrations. Inhibitors or neutralizers of preservatives, approved by the Administrator, may be considered in determining the proper ratio."], ["9:9:1.0.1.5.51.0.75.12", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.26 Detection of viable bacteria and fungi except in live vaccine.", "APHIS", "", "", "[35 FR 16039, Oct. 13, 1970, as amended at 37 FR 2430, Feb. 1, 1972; 39 FR 21042, June 18, 1974; 40 FR 758, Jan. 3, 1975; 40 FR 14084, Mar. 28, 1975; 56 FR 66784, Dec. 26, 1991]", "Each serial and subserial of biological product except live vaccines shall be tested as prescribed in this section unless otherwise specified by the Administrator. When cell lines, primary cells, or ingredients of animal origin used in the preparation of a biological product are required to be free of viable bacteria and fungi, they shall also be tested as prescribed in this section.\n\n(a) The media to be used shall be as follows:\n\n(1) Fluid Thioglycollate Medium with 0.5 percent beef extract shall be used to test for bacteria in biological products containing clostridial toxoids, bacterins, and bacterin-toxoids.\n\n(2) Fluid Thioglycollate Medium with or without 0.5 percent beef extract shall be used to test for bacteria in biological products other than clostridial toxoids, bacterins, and bacterin-toxoids.\n\n(3) Soybean-Casein Digest Medium shall be used to test biological products for fungi; provided, that Fluid Thioglycollate Medium without beef extract shall be substituted when testing biological products containing mercurial preservatives.\n\n(b) Test procedure:\n\n(1) Ten test vessels shall be used for each of two media selected in accordance with paragraph (a)(1), (a)(2), or (a)(3) of this section. Each test vessel shall contain sufficient medium to negate the bacteriostatic or fungistatic activity in the inoculum as determined in \u00a7 113.25(d).\n\n(2) Inoculum:\n\n(i) When completed product is tested, 10 final container samples from each serial and each subserial shall be tested. One ml from each sample shall be inoculated into a corresponding individual test vessel of culture medium:  Provided,  That, if each final container sample contains less than 2 ml, one-half of the contents shall be used as inoculum for each test vessel.\n\n(ii) When cell lines, primary cells, or ingredients of animal origin are tested, at least a 20 ml test sample from each lot shall be tested. One ml shall be inoculated into each test vessel of medium.\n\n(3) Incubation shall be for an observation period of 14 days at 30 \u00b0to 35 \u00b0C. to test for bacteria and 14 days at 20 \u00b0to 25 \u00b0C. to test for fungi.\n\n(4) If the inoculum renders the medium turbid so that the absence of growth cannot be determined by visual examination, subcultures shall be made on the seventh to eleventh day from biological products prepared from clostridial toxoids, bacterins, and bacterin-toxoids and the third to seventh day for other biological products. Portions of the turbid medium in amounts of not less than 1.0 ml. shall be transferred to 20 to 25 ml. of fresh medium, and incubated the balance of the 14-day period.\n\n(c) Examine the contents of all test vessels for macroscopic microbial growth during the incubation period. When demonstrated by adequate controls to be invalid, the test may be repeated. For each set of test vessels representing a serial or subserial in a valid test, the following rules shall apply:\n\n(1) If no growth is found in any test vessel, the serial or subserial meets the requirements of the test.\n\n(2) If growth is found in any test vessel, one retest to rule out faulty technique may be conducted using 20 unopened final container samples.\n\n(3) If growth is found in any test vessel of the final test, the serial, subserial, or ingredients to be used in the preparation of a biological product, as the case may be, is unsatisfactory."], ["9:9:1.0.1.5.51.0.75.13", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.27 Detection of extraneous viable bacteria and fungi in live vaccines.", "APHIS", "", "", "[48 FR 28430, June 22, 1983, as amended at 56 FR 66784, Dec. 26, 1991]", "Unless otherwise specified by the Administrator or elsewhere exempted in this part, each serial and subserial of live vaccine and each lot of Master Seed Virus and Master Seed Bacteria shall be tested for extraneous viable bacteria and fungi as prescribed in this section. A Master Seed found unsatisfactory shall not be used in vaccine production and a serial found unsatisfactory shall not be released.\n\n(a)  Live viral vaccines.  Each serial and subserial of live viral vaccine shall be tested for purity as prescribed in this paragraph. However, products of chicken embryo origin recommended for administration other than by parenteral injection may be tested as provided in paragraph (e) of this section.\n\n(1) Soybean Casein Digest Medium shall be used.\n\n(2) Ten final container samples from each serial and subserial shall be tested.\n\n(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water.\n\n(4) To test for bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 120 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in \u00a7 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 \u00b0to 35 \u00b0C for 14 days.\n\n(5) To test for fungi, place 0.2 ml of vaccine from each final container sample into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in \u00a7 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 \u00b0to 25 \u00b0C for 14 days.\n\n(6) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.\n\n(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:\n\n(i) If growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.\n\n(ii) If no growth is found in 9 or 10 of the test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.\n\n(iii) If growth is found in four or more test vessels in the initial test, or two or more in a retest, the serial or subserial is unsatisfactory.\n\n(b)  Live bacterial vaccines.  Each serial or subserial of live bacterial vaccine shall be tested for purity as prescribed in this paragraph.\n\n(1) Soybean Casein Digest Medium and Fluid Thioglycollate Medium shall be used.\n\n(2) Ten final container samples from each serial and subserial shall be tested.\n\n(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.\n\n(4) To test for extraneous bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Fluid Thioglycollate Medium. Additional medium shall be used if the determination required in \u00a7 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 \u00b0to 35 \u00b0C for 14 days.\n\n(5) To test for extraneous fungi, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in \u00a7 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 \u00b0to 25 \u00b0C for 14 days.\n\n(6) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subculturing, microscopic examination, or both.\n\n(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:\n\n(i) If extraneous growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.\n\n(ii) If no extraneous growth is found in 9 or 10 test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.\n\n(iii) If extraneous growth is found in 4 or more test vessels in the initial test, or 2 or more in a retest, the serial or subserial is unsatisfactory.\n\n(c)  Master Seed Virus.  Not less than 4 ml of each lot of Master Seed Virus shall be tested. Frozen liquid Master Seed Virus shall be thawed, and desiccated Master Seed Virus shall be rehydrated with Soybean Casein Digest Medium immediately prior to starting the test.\n\n(1) To test for bacteria, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 120 ml of Soybean Casein Digest Medium. Incubation shall be at 30 \u00b0to 35 \u00b0C for 14 days.\n\n(2) To test for fungi, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 \u00b0to 25 \u00b0C for 14 days.\n\n(3) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.\n\n(4) For each set of test vessels representing a lot of Master Seed Virus tested according to these procedures, the following rules shall apply:\n\n(i) If growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Virus.\n\n(ii) If growth is found in any test vessel of the final test, the lot of Master Seed Virus is unsatisfactory.\n\n(d)  Master Seed Bacteria.  Not less than 4 ml of each lot of Master Seed Bacteria shall be tested. Frozen liquid Master Seed Bacteria shall be thawed, and desiccated Master Seed Bacteria shall be rehydrated with sterile purified water immediately prior to starting the test.\n\n(1) To test for extraneous bacteria, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Fluid Thioglycollate Medium. Incubation shall be at 30 \u00b0to 35 \u00b0C for 14 days.\n\n(2) To test for extraneous fungi, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 \u00b0to 25 \u00b0C for 14 days.\n\n(3) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.\n\n(4) For each set of test vessels representing a lot of Master Seed Bacteria tested according to these procedures, the following rules shall apply:\n\n(i) If extraneous growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Bacteria.\n\n(ii) If extraneous growth is found in any test vessel of the final test, the lot of Master Seed Bacteria is unsatisfactory.\n\n(e) Live viral vaccines of chicken embryo origin recommended for administration other than by parenteral injection, which were not tested or have not been found free of bacteria and fungi by the procedures prescribed in paragraph (a) of this section, may be tested according to the procedures prescribed in this paragraph.\n\n(1) Brain Heart Infusion Agar shall be used with 500 Kinetic (Kersey) units of penicillinase per ml of medium added just prior to pouring the plates.\n\n(2) Ten final containers from each serial and each subserial shall be tested.\n\n(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the quantity recommended on the label using the accompanying sterile diluent or sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.\n\n(4) From each container sample, each of 2 plates shall be inoculated with vaccine equal to 10 doses if the vaccine is recommended for poultry or 1 dose if the vaccine is recommended for other animals. Twenty ml of medium shall be added to each plate. One plate shall be incubated at 30 \u00b0to 35 \u00b0for 7 days and the other plate shall be incubated at 20 \u00b0to 25 \u00b0C for 14 days.\n\n(5) Colony counts shall be made for each plate at the end of the incubation period. An average colony count for the 10 samples representing the serial or subserial shall be made for each incubation condition.\n\n(6) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:\n\n(i) If the average count at either incubation condition exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals in the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final containers.\n\n(ii) If the average count at either incubation condition of the final test for a serial or subserial exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals, the serial or subserial is unsatisfactory."], ["9:9:1.0.1.5.51.0.75.14", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.28 Detection of mycoplasma contamination.", "APHIS", "", "", "[38 FR 29887, Oct. 30, 1973, as amended at 41 FR 6752, Feb. 13, 1976; 41 FR 32882, Aug. 6, 1976]", "The heart infusion test, using heart infusion broth and heart infusion agar, provided in this section shall be conducted when a test for mycoplasma contamination is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.\n\n(a) Media additives provided in this paragraph shall be prepared as follows:\n\n(1) DPN-Cysteine Solution:\n\n(i) Use Nicotinamide adenine dinucleotide (oxidized) and L-Cysteine hydrochloride.\n\n(ii) Prepare 1 gram/100 milliliters (ml) purified water (1 percent solution) of each. Mix the solutions together; the cysteine reduces the DPN. Filter sterilize, dispense in appropriate amounts and store frozen at \u221220 degrees centigrade.\n\n(2) Inactivated horse serum\u2014horse serum which has been inactivated at 56 \u00b0C for 30 minutes.\n\n(b) Heart infusion broth shall be prepared as provided in this paragraph.\n\n(1) Dissolve in 970 ml of purified water, 25 grams of heart infusion broth, 10 grams of proteose peptone No. 3, and either 5 grams of yeast autolysate or 5 ml of fresh yeast extract.\n\n(2) Add the following:\n\n(3) Adjust pH to 7.9 with NaOH, filter sterilize, and dispense 100 ml aliquots into 125 ml flasks and store until needed.\n\n(4) Add 2 ml of DPN-Cysteine solution to each 100 ml of broth on day of use.\n\n(c) Heart Infusion Agar shall be prepared as provided in this paragraph.\n\n(1) Dissolve in 900 ml of purified water by boiling the following:\n\n(2) Cool the medium and adjust pH to 7.9 with NaOH.\n\n(3) Autoclave the medium.\n\n(4) Cool the medium 30 minutes in a 56 \u00b0C waterbath.\n\n(5) Dissolve 5 grams of yeast autolysate in 100 ml of distilled water, filter sterilize, and add to the medium.\n\n(6) Add to the medium:\n\n126 ml of inactivated horse serum \n \n 21 ml of DPN-Cysteine solution \n \n 525,000 units of Penicillin. \n \n Dispense 10 ml aliquots into 60 \u00d7 15 mm disposable culture dishes or petri dishes.\n\n126 ml of inactivated horse serum\n\n21 ml of DPN-Cysteine solution\n\n525,000 units of Penicillin.\n\nDispense 10 ml aliquots into 60 \u00d7 15 mm disposable culture dishes or petri dishes.\n\n(d) The test procedure provided in this paragraph shall be followed when conducting the mycoplasma detection test.\n\n(1) Preparation of inoculum. Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the volume recommended on the label with mycoplasma medium. In the case of a lyophilized biological product, e.g., 1,000 dose vial of poultry vaccine to be administered via the drinking water, the vaccine shall be rehydrated to 30 ml with mycoplasma medium. In the case of a cell line or a sample of primary cells, the inoculum shall consist of the resuspended cells. Control tests shall be established as provided in paragraph (d)(4) of this section.\n\n(2) Inoculation of plate. Plate 0.1 ml of inoculum on an agar plate and make a short, continuous streak across the plate with a pipet. Tilt the plate to allow the inoculum to flow over the surface.\n\n(3) Inoculation of flask of medium. Transfer 1 ml of the inoculum into a flask containing 100 ml mycoplasma medium and mix thoroughly. Incubate the flask at 33 to 37 \u00b0C for 14 days during which time, one of four agar plates shall be streaked with 0.1 ml of material from the incubating flask of inoculated medium on the 3d day, one on the 7th day, one on the 10th day, and one on the 14th day post-inoculation.\n\n(4) Control tests shall be conducted simultaneously with the detection test using techniques provided in paragraphs (d)(2) and (3) of this section, except the inoculum for the positive control test shall be selected mycoplasma cultures and the negative control test shall be uninoculated medium from the same lot used in the detection test.\n\n(5) All plates shall be incubated in a high humidity, 4-6 percent CO 2  atmosphere at 33 \u00b0to 37 \u00b0C for 10-14 days and examined with a stereoscopic microscope at 35x to 100x or with a regular microscope at 100x.\n\n(e) Interpretation of test results.\n\n(1) If growth appears on at least one of the plates in the positive control test and does not appear on any of the plates in the negative control test, the test is valid.\n\n(2) If mycoplasma colonies are found on any of the plates inoculated with material being tested, the results are positive for mycoplasma contamination."], ["9:9:1.0.1.5.51.0.75.15", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.29 Determination of moisture content in desiccated biological products.", "APHIS", "", "", "[68 FR 57608, Oct. 6, 2003]", "Methods provided in this section must be used when a determination of moisture content in desiccated biological products is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product. Firms currently using methods other than those provided in this section for determining the moisture content in desiccated biological products have until November 5, 2004 to update their Outlines of Production to be in compliance with this requirement.\n\n(a) Final container samples of completed product shall be tested. The weight loss of the sample due to drying in a vacuum oven shall be determined. All procedures should be performed in an environment with a relative humidity less than 45 percent. The equipment necessary to perform the test is as follows:\n\n(1) Cylindrical weighing bottles with airtight glass stoppers.\n\n(2) Vacuum oven equipped with validated thermometer and thermostat. A suitable air-drying device should be attached to the inlet valve.\n\n(3) Balance, accurate to 0.1 mg (rated precision \u00b10.01mg).\n\n(4) Desiccator jar equipped with phosphorous pentoxide, silica gel, or equivalent.\n\n(5) Desiccated vaccine in original sealed vial. Sample and control should be kept at room temperature in their original airtight containers until use.\n\n(b) Test procedure:\n\n(1) Thoroughly cleaned and labeled sample-weighing bottles with stoppers should be allowed to dry at 60 \u00b13 \u00b0C under vacuum at less than 2.5 kPa.\n\n(i) Transfer hot bottles and stoppers into the desiccator and allow to cool to room temperature.\n\n(ii) After bottles have cooled, insert stoppers and weigh and record the weights of the bottles as \u201cA.\u201d\n\n(iii) Return weighing bottles to the desiccator.\n\n(2) Remove the sample container seal.\n\n(i) Using a spatula, break up the sample plug and transfer the required amount of sample to the previously tared weighing bottle.\n\n(ii) Insert the stopper and weigh and record the weights of the weighing bottles as \u201cB.\u201d\n\n(3) Place the weighing bottle with the stopper at an angle in the vacuum oven. Set the vacuum to <2.5 kPa and the temperature to 60 \u00b13 \u00b0C.\n\n(4) After a minimum of 3 hours of drying time, turn off the vacuum pump and allow dry air to bleed into the oven until the pressure inside the oven is equalized with the prevailing atmospheric pressure.\n\n(5) While the bottle is still warm, replace the stopper in its normal position and transfer the weighing bottle to the desiccator.\n\n(i) Allow a minimum of 2 hours for the weighing bottle to cool to room temperature or for its weight to reach equilibrium.\n\n(ii) Weigh, and record the weight as \u201cC.\u201d\n\n(6) Calculate the percentage of moisture in the original sample as follows:\n\n(B\u2212C)/(B\u2212A) \u00d7 (100) = Percentage of residual moisture, where:\n\nA = tare weight of weighing bottle\n\nB\u2212A = weight of sample before drying\n\nB\u2212C = weight of sample after drying\n\n(7) The results are considered satisfactory if the percentage of residual moisture is less than or equal to the manufacturer's specification."], ["9:9:1.0.1.5.51.0.75.16", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.30 Detection of Salmonella contamination.", "APHIS", "", "", "[38 FR 29888, Oct. 30, 1973]", "The test for detection of Salmonella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.\n\n(a) Samples shall be collected from the bulk suspension before bacteriostatic or bactericidal agents have been added. When tissue culture products are to be tested, 1 ml of tissue extract used as the source of cells or 1 ml of the minced tissue per se shall be tested.\n\n(b) Five ml of the liquid vaccine suspension shall be used to inoculate each 100 ml of liquid broth medium (tryptose and either selenite F or tetrathionate). The inoculated media shall be incubated 18-24 hours at 35-37 \u00b0C.\n\n(c) Transfers shall be made to either MacConkey agar or Salmonella-Shigella agar, incubated for 18-24 hours and examined.\n\n(d) If no growth typical of Salmonella is noted, the plates shall be incubated an additional 18-24 hours and again examined.\n\n(e) If suspicious colonies are observed, further subculture on suitable media shall be made for positive identification. If Salmonella is found, the bulk suspension is unsatisfactory."], ["9:9:1.0.1.5.51.0.75.17", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.31 Detection of avian lymphoid leukosis.", "APHIS", "", "", "[38 FR 29888, Oct. 30, 1973, as amended at 38 FR 32917, Nov. 29, 1973; 39 FR 21042, June 18, 1974; 56 FR 66784, Dec. 26, 1991]", "The complement-fixation test for detection of avian lymphoid leukosis provided in this section shall be conducted on all biological products containing virus which has been propagated in substrates of chicken origin:  Provided,  An inactivated viral product shall be exempt from this requirement if the licensee can demonstrate to Animal and Plant Health Inspection Service that the agent used to inactivate the vaccine virus would also inactivate lymphoid leukosis virus.\n\n(a) Propagation of contaminating lymphoid leukosis viruses, if present, shall be done in chick embryo cell cultures.\n\n(1) Each vaccine virus, cytopathic to chick embryo fibroblast cells, shall be effectively neutralized, inactivated, or separated so that minimal amounts of lymphoid leukosis virus can be propagated on cell culture during the 21-day growth period. If a vaccine virus cannot be effectively neutralized, inactivated, or separated, a sample of another vaccine prepared the same week from material harvested from each source flock (or other sampling procedure acceptable to Animal and Plant Health Inspection Service) used for the preparation of the questionable vaccine virus that cannot be neutralized, inactivated, or separated shall be tested each week during the preparation of such questionable vaccine.\n\n(2) When cell cultures are tested, 5 ml of the final cell suspension as prepared for seeding of production cell cultures shall be used as inoculum. When vaccines are tested, the equivalent of 200 doses of Newcastle disease vaccine or 500 doses of other vaccines for use in poultry, or one dose of vaccine for use in other animals shall be used as inoculum. Control cultures shall be prepared from the same cell suspension as the cultures for testing the vaccine.\n\n(3) Uninoculated chick embryo fibroblast cell cultures shall act as negative controls. One set of chick fibroblast cultures inoculated with subgroup A virus and another set inoculated with subgroup B virus shall act as positive controls, A and B respectively.\n\n(4) The cell cultures shall be propagated at 35-37 \u00b0C for at least 21 days. They shall be passed when necessary to maintain viability and samples harvested from each passage shall be tested for group specific antigen.\n\n(b) The microtiter complement-fixation test shall be performed using either the 50 percent or the 100 percent hemolytic end point technique to determine complement unitage. Five 50 percent hemolytic units or two 100 percent hemolytic units of complement shall be used for each test.\n\n(1) All test materials, including positive and negative controls, shall be stored at \u221260 \u00b0C or colder until used in the test. Before use, each sample shall be thawed and frozen three times to disrupt intact cells and release the group specific antigen.\n\n(2) The antiserum used in the microtiter complement-fixation test shall be a standard reagent supplied or approved by the Animal and Plant Health Inspection Service. Four units of antiserum shall be used for each test.\n\n(3) Presence of complement-fixing activity in the harvested samples (from passages) at the 1:4 or higher dilution, in the absence of anticomplementary activity, shall be considered a positive test unless the activity can definitely be established to be caused by something other than lymphoid leukosis virus, subgroups A and/or B. Activity at the 1:2 dilution shall be considered suspicious and the sample further subcultured to determine presence or absence of the group specific antigen.\n\n(4) Biological products or primary cells which are found contaminated with lymphoid leukosis viruses are unsatisfactory. Source flocks from which contaminated material was obtained are also unsatisfactory."], ["9:9:1.0.1.5.51.0.75.18", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.32 Detection of Brucella contamination.", "APHIS", "", "", "[38 FR 29888, Oct. 30, 1973]", "The test for detection of Brucella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production for the product.\n\n(a) One ml of the minced tissue used as the source of cells or 1 ml of the extract of the tissue prior to the addition of antibiotics, diluent and stabilizer, shall be inoculated onto each of three tryptose agar plates and incubated in a 10 percent CO 2  atmosphere at a temperature of 35-37 \u00b0C for at least 7 days.\n\n(b) If colonies are identified as Brucella, the biological product is unsatisfactory.\n\n(c) If colonies suspicious of Brucella are observed but cannot be identified as a Brucella species, either\n\n(1) The biological product shall be regarded as unsatisfactory and destroyed; or\n\n(2) Further subculture or other procedures shall be carried out until a positive identification can be made."], ["9:9:1.0.1.5.51.0.75.19", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.33 Mouse safety tests.", "APHIS", "", "", "[38 FR 34727, Dec. 18, 1973, as amended at 39 FR 16857, May 10, 1974; 72 FR 72564, Dec. 21, 2007]", "One of the mouse safety tests provided in this section shall be conducted when such test is prescribed in a Standard Requirement or in the filed Outline of Production for a biological product recommended for animals other than poultry:  Provided,  That if the inherent nature of one or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for the animals for which it is recommended, the licensee shall demonstrate the safety of such product by an acceptable test written into such Outline of Production.\n\n(a) Final container samples of completed product from live virus vaccines shall be tested for safety using young adult mice in accordance with the test provided in this paragraph.\n\n(1) Vaccine prepared for use as recommended on the label shall be tested by inoculating eight mice intraperitoneally or subcutaneously with 0.5 mL (the inoculation volume may be divided among more than one injection site), and the animals observed for 7 days.\n\n(2) If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated:  Provided,  That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.\n\n(b) Bulk or final container samples of completed product from liquid products, such as but not limited to antiserums and bacterins, shall be tested for safety in accordance with the test provided in this paragraph.\n\n(1) Unless otherwise prescribed in the Standard Requirement or approved in a filed Outline of Production for the product, a 0.5 ml dose shall be injected intraperitoneally or subcutaneously into eight mice and the animals observed for 7 days.\n\n(2) If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated:  Provided,  That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory."], ["9:9:1.0.1.5.51.0.75.20", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.34 Detection of hemagglutinating viruses.", "APHIS", "", "", "[38 FR 29889, Oct. 30, 1973]", "The test for detection of hemagglutinating viruses provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.\n\n(a) Final container samples of completed product rehydrated as recommended on the label shall be used as inoculum:  Provided,  That poultry vaccines distributed without diluent shall be rehydrated with 30 ml of sterile distilled water per 1,000 doses and used as inoculum. When one or more fractions are to be used in combination with Newcastle Disease Vaccine, test samples shall be collected from bulk suspensions of each prior to mixing with the Newcastle Disease Vaccine.\n\n(b) Each of ten 9- to 10-day-old embryonating eggs from Newcastle disease susceptible flocks shall be inoculated into the allantoic cavity with 0.2 ml of the undiluted inoculum.\n\n(1) Test five uninoculated embryos of the same age and from the same flock as those used for the test as negative controls.\n\n(2) Test an allantoic fluid sample of Newcastle disease virus as a positive control.\n\n(c) Three to five days post-inoculation, a sample of allantoic fluid from each egg shall be tested separately by a rapid plate test for hemagglutinating activity using a 0.5 percent suspension of fresh chicken red blood cells.\n\n(d) If the results are inconclusive, one or two blind passages shall be made using fluids from each of the original test eggs. Fluids from dead and live embryos may be pooled separately for inoculum in these passages.\n\n(e) If hemagglutinating activity attributable to the product is observed, the serial is unsatisfactory."], ["9:9:1.0.1.5.51.0.75.21", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.35 Detection of viricidal activity.", "APHIS", "", "", "[44 FR 25412, May 1, 1979, as amended at 56 FR 66784, Dec. 26, 1991; 64 FR 43044, Aug. 9, 1999]", "The test for detection of viricidal activity provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in the filed Outline of Production for each inactivated liquid biological product used as diluent for a desiccated live virus vaccine in a combination package.\n\n(a) Bulk or final container samples of completed product from each serial shall be tested.\n\n(b) The product shall be tested with each virus fraction for which it is to be used as a diluent. If the vaccine to be rehydrated contains more than one virus fraction, the test shall be conducted with each fraction after neutralization of the other fraction(s), and/or dilution of the vaccine beyond the titer range of the other fraction(s), or the test shall be conducted using representative single-fraction desiccated vaccines which are prepared by the licensee and which are licensed.  Provided,  That the Administrator may authorize licensees to prepare and use unlicensed single-fraction vaccines for this purpose.\n\n(c) Test procedure: (1) Rehydrate at least two vials of the vaccine with the liquid product under test according to label recommendations and pool the contents.\n\n(2) Rehydrate at least two vials of the vaccine with the same volume of sterile purified water and pool the contents.\n\n(3) Neutralize to remove other fractions, if necessary.\n\n(4) Hold the two pools of vaccine at room temperature (20 \u00b0to 25 \u00b0C) for 2 hours. The holding period shall begin when rehydration is completed.\n\n(5) Titrate the virus(es) in each pool of vaccine as provided in the filed Outline of Production or an applicable standard requirement.\n\n(6) Compare respective titers.\n\n(d) If the titer of the vaccine virus(es) rehydrated with the product under test is more than 0.7 log 10  below the titer of the vaccine virus(es) rehydrated with sterile purified water, the product is unsatisfactory for use as diluent.\n\n(e) If the product is unsatisfactory in the first test, one retest to rule out faulty techniques may be conducted using four vials of the vaccine for each pool and the acceptability of the product judged by the results of the second test.\n\n(f) Liquid products found to be unsatisfactory for use as diluent by this test are not prohibited from release as separate licensed products if labeled as prescribed in \u00a7 112.7(g)."], ["9:9:1.0.1.5.51.0.75.22", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.36 Detection of pathogens by the chicken inoculation test.", "APHIS", "", "", "[38 FR 29889, Oct. 30, 1973, as amended at 39 FR 21042, June 18, 1974; 43 FR 7610, Feb. 24, 1978]", "The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.\n\n(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.\n\n(b) At least 25 healthy susceptible young chickens, properly identified and obtained from the same source and hatch, shall be immunized at least 14 days prior to being put on test. The immunizing agent shall be the same as the product to be tested but from a serial previously tested and found satisfactory.\n\n(c) At least 20 of the previously immunized birds shall be inoculated with 10 label doses of the vaccine being tested by each of the following routes: Subcutaneous, intratracheal, eye-drop, and comb scarification (1 cm \n 2 ). Twenty birds may be used for each route or combination of routes.\n\n(d) At least five birds shall be isolated as control birds.\n\n(e) All birds shall be observed for 21 days for signs of septicemic diseases, respiratory diseases, or other pathologic conditions.\n\n(f) If the controls remain healthy and unfavorable reactions attributable to the product occur in the vaccinates, the serial or subserial tested is unsatisfactory. If the controls do not remain healthy or if unfavorable reactions not attributable to the product occur in the vaccinates, or both, the test shall be declared a No Test and may be repeated:  Provided,  That, if the test is not repeated, the serial of subserial tested shall be considered unsatisfactory."], ["9:9:1.0.1.5.51.0.75.23", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.37 Detection of pathogens by the chicken embryo inoculation test.", "APHIS", "", "", "[38 FR 29889, Oct. 30, 1973, as amended at 39 FR 21042, June 18, 1974]", "The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.\n\n(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.\n\n(b) One volume of the prepared vaccine shall be mixed with up to nine volumes of sterile heat-inactivated specific antiserum to neutralize the vaccine virus in the product. Each lot of antiserum shall be demonstrated by virus neutralization tests not to inhibit other viruses known to be possible contaminants.\n\n(c) After neutralization, 0.2 ml of the vaccine-serum mixture shall be inoculated into each of at least 20 fully susceptible chicken embryos.\n\n(1) Twenty embryos, 9 to 11 days old, shall be inoculated on the chorio-allantoic membrane (CAM) with 0.1 ml, and in the allantoic sac with 0.1 ml.\n\n(2) Eggs shall be candled daily for 7 days. Deaths occurring during the first 24 hours shall be disregarded but at least 18 viable embryos shall survive 24 hours post-inoculation for a valid test. Examine all embryos and CAM's from embryos which die after the first day. When necessary, embryo subcultures shall be made to determine the cause of a death. The test shall be concluded on the seventh day post-inoculation and the surviving embryos (including CAM's) examined.\n\n(d) If death and/or abnormality attributable to the inoculum occur, the serial is unsatisfactory:  Provided,  That, if there is a vaccine virus override, the test may be repeated, using a higher titered antiserum."], ["9:9:1.0.1.5.51.0.75.24", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.38 Guinea pig safety test.", "APHIS", "", "", "[39 FR 16857, May 10, 1974; 39 FR 20368, June 10, 1974]", "The guinea pig safety test provided in this section shall be conducted when prescribed in a Standard Requirement or approved Outline of Production for a biological product. When desiccated products are tested, final container samples of completed product prepared for administration in the manner recommended on the label shall be used. When liquid products are tested, either bulk or final container samples of completed product shall be used.\n\n(a) Unless otherwise specified in the Standard Requirement or approved Outline of Production for the product, a 2 ml dose shall be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals observed for 7 days.\n\n(b) If unfavorable reactions attributable to the product occur in either of the guinea pigs during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated:  Provided,  That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory."], ["9:9:1.0.1.5.51.0.75.25", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.39 Cat safety tests.", "APHIS", "", "", "[44 FR 58898, Oct. 12, 1979, as amended at 56 FR 66784, Dec. 26, 1991]", "The safety tests provided in this section shall be conducted when prescribed in a standard requirement or in the filed Outline of Production for a biological product recommended for use in cats.\n\n(a) The cat safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.\n\n(1) The test animals shall be determined to be susceptible to the virus under test as follows:\n\n(i) Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of the virus. Blood samples shall also be drawn and individual serum samples tested for antibody to the virus.\n\n(ii) The cats shall be considered susceptible if swabs are negative for virus isolation and the serums are free of virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other serum-neutralization test of equal sensitivity.\n\n(iii) When determining susceptibility to a virus which does not lend itself to the methods in paragraphs (a)(1)(i) and (ii) of this section, a method acceptable to Animal and Plant Health Inspection Service shall be used.\n\n(2) Each of at least 10 susceptible cats shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one cat dose of the vaccine, by the method to be recommended on the label, and the cats observed each day for 14 days.\n\n(3) If unfavorable reactions attributable to the virus occur in any of the cats during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared a No Test and repeated:  Provided,  That, if not repeated, the Master Seed Virus shall be unsatisfactory.\n\n(b) The cat safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.\n\n(1) Each of two healthy cats shall be administered 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.\n\n(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated:  Provided,  That, if not repeated, the serial shall be unsatisfactory."], ["9:9:1.0.1.5.51.0.75.26", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.40 Dog safety tests.", "APHIS", "", "", "[60 FR 14358, Mar. 17, 1995]", "The safety tests provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a biological product recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the procedures in this section may not be released for shipment.\n\n(a) The dog safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.\n\n(1) The test animals shall be determined to be susceptible to the virus under test by a method acceptable to the Animal and Plant Health Inspection Service.\n\n(2) Each of at least 10 susceptible dogs shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose of the vaccine, by the method recommended on the label, and the dog shall be observed each day for 14 days.\n\n(3) If unfavorable reactions attributable to the virus occur in any of the dogs during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared a No Test and may be repeated:  Provided:  That, if the test is not repeated, the Master Seed Virus shall be considered unsatisfactory.\n\n(b) The dog safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.\n\n(1) Each of two healthy dogs shall be administered 10 dog doses by the method recommended on the label and the dogs shall be observed each day for 14 days.\n\n(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the biological product, the test shall be declared a No Test and may be repeated:  Provided,  That, if the test is not repeated, the serial shall be considered unsatisfactory."], ["9:9:1.0.1.5.51.0.75.27", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.41 Calf safety test.", "APHIS", "", "", "[39 FR 27428, July 29, 1974]", "The calf safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.\n\n(a)  Test procedure.  Each of two calves shall be injected with the equivalent of 10 doses of vaccine administered in the manner recommended on the label and observed each day for 21 days.\n\n(b)  Interpretation.  If unfavorable reactions attributable to the product occur in either of the calves during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated:  Provided,  That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory."], ["9:9:1.0.1.5.51.0.75.28", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.42 Detection of lymphocytic choriomeningitis contamination.", "APHIS", "", "", "[42 FR 6794, Feb. 4, 1977]", "The test for detection of lymphocytic choriomeningitis (LCM) virus provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production. Vaccine virus may be neutralized with specific antiserum when necessary.\n\n(a) Each of at least 10 mice obtained from a source free of LCM shall be injected in the footpad of a hindfoot with 0.02 ml of the material being tested and observed each day for 21 days.\n\n(b) If any of the mice show swelling in the injected footpad or if more than one becomes systemically abnormal, the material being tested is unsatisfactory."], ["9:9:1.0.1.5.51.0.75.29", 9, "Animals and Animal Products", "I", "E", "113", "PART 113\u2014STANDARD REQUIREMENTS", "", "", "", "\u00a7 113.43 Detection of chlamydial agents.", "APHIS", "", "", "[44 FR 58899, Oct. 12, 1979]", "The test for chlamydial agents provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in a filed Outline of Production.\n\n(a) The yolk sac of 6-day-old chicken embryos shall be injected. Three groups of 10 embryos shall be used sequentially.\n\n(1) The inoculum for each embryo in the first group shall consist of 0.5 ml of a mixture of equal parts of the seed virus with phosphate buffered saline that may contain Streptomycin, Vancomycin, Kanamycin, or a combination thereof. Not more than 2 mg/ml of each antibiotic shall be used.\n\n(2) On the 10th day postinoculation, the yolk sac of viable embryos shall be harvested, pooled, homogenized as a 20 percent suspension in phosphate buffered saline antibiotic diluent, and 0.5 ml of the mixture injected into the second group of chicken embryos. This process shall be repeated for the injection of the third group of embryos using the yolk sacs of viable embryos from the second group.\n\n(3) For each of the three passages, embryo deaths occurring within 48 hours of injection shall be disregarded, except that if more than three such deaths occur at any passage, that passage shall be repeated.\n\n(b) If one or more embryo deaths occur at any passage after 48 hours postinjection, the yolk sacs from each of the dead embryos shall be subcultured into 10 additional embryos. If one or more embryo deaths again occur due to chlamydial agents, the Master Seed Virus is unsatisfactory for use to produce vaccine."]], "truncated": false, "filtered_table_rows_count": 196, "expanded_columns": [], "expandable_columns": [], "columns": ["section_id", "title_number", "title_name", "chapter", "subchapter", "part_number", "part_name", "subpart", "subpart_name", "section_number", "section_heading", "agency", "authority", "source_citation", "amendment_citations", "full_text"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select section_id, title_number, title_name, chapter, subchapter, part_number, part_name, subpart, subpart_name, section_number, section_heading, agency, authority, source_citation, amendment_citations, full_text from cfr_sections where \"part_number\" = :p0 order by section_id limit 101", "params": {"p0": "113"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=113", "results": [{"value": 9, "label": 9, "count": 125, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&title_number=9", "selected": false}, {"value": 46, "label": 46, "count": 55, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&title_number=46", "selected": false}, {"value": 21, "label": 21, "count": 10, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&title_number=21", "selected": false}, {"value": 40, "label": 40, "count": 6, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&title_number=40", "selected": false}], "truncated": false}, "agency": {"name": "agency", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=113", "results": [{"value": "APHIS", "label": "APHIS", "count": 125, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&agency=APHIS", "selected": false}, {"value": "USCG", "label": "USCG", "count": 55, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&agency=USCG", "selected": false}, {"value": "FDA", "label": "FDA", "count": 10, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&agency=FDA", "selected": false}, {"value": "EPA", "label": "EPA", "count": 6, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&agency=EPA", "selected": false}], "truncated": false}, "part_number": {"name": "part_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=113", "results": [{"value": "113", "label": "113", "count": 196, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "title_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&_facet=title_name"}, {"name": "subchapter", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&_facet=subchapter"}, {"name": "part_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&_facet=part_name"}, {"name": "subpart", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&_facet=subpart"}, {"name": "subpart_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&_facet=subpart_name"}], "next": "9~3A9~3A1~2E0~2E1~2E5~2E51~2E0~2E75~2E29,9~3A9~3A1~2E0~2E1~2E5~2E51~2E0~2E75~2E29", "next_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=113&_next=9~3A9~3A1~2E0~2E1~2E5~2E51~2E0~2E75~2E29%2C9~3A9~3A1~2E0~2E1~2E5~2E51~2E0~2E75~2E29&_sort=section_id", "private": false, "allow_execute_sql": true, "query_ms": 2304.2081429157406, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}