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| 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 |
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| 21:21:2.0.1.1.13.1.1.1 | 21 | Food and Drugs | I | B | 113 | PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | A | Subpart A—General Provisions | § 113.3 Definitions. | FDA | For the purposes of this part, the following definitions apply: (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. (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. (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. (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. (e) Commercial sterility: (1) “Commercial sterility” of thermally processed food means the condition achieved— (i) By the application of heat which renders the food free of— ( a ) Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and ( b ) Viable microorganisms (including spores) of public health significance; or (ii) By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. (2) “Commercial sterility” of equipment and containers used for aseptic processing and packaging of food means the condition achieved by application of heat, chemical sterilant(s), or other appropriate treatment that renders the equipment and containers free of viable microorganisms having public health significance, as well as microorganisms of nonhealth significance, capable of reproducing in the food under normal nonrefr… | ||||
| 21:21:2.0.1.1.13.1.1.2 | 21 | Food and Drugs | I | B | 113 | PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | A | Subpart A—General Provisions | § 113.5 Current good manufacturing practice. | FDA | The criteria in §§ 113.10, 113.40, 113.60, 113.81, 113.83, 113.87, 113.89, and 113.100 shall apply in determining whether the facilities, methods, practices, and controls used by the commercial processor in the manufacture, processing, or packing of low-acid foods in hermetically sealed containers are operated or administered in a manner adequate to protect the public health. | ||||
| 21:21:2.0.1.1.13.1.1.3 | 21 | Food and Drugs | I | B | 113 | PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | A | Subpart A—General Provisions | § 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—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | C | Subpart C—Equipment | § 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 —(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. (i) The design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. (ii) Records of the accuracy of the temperature-indicating device and of a reference device that is maintained by the processor shall be established and maintained in accordance with § 113.100(c) and (d). (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate calibrated reference device shall be repaired before further use or replaced. (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of a mercury-in-glass thermometer shall not exceed 17 °F per inch (4 °C per centimeter) of graduated scale. A mercury-in-glass thermometer that has a divided mercury column shall be considered defective. (v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. Ex… | |||
| 21:21:2.0.1.1.13.4.1.1 | 21 | Food and Drugs | I | B | 113 | PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | D | Subpart D—Control of Components, Food Product Containers, Closures, and In-Process Materials | § 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. (1) Teardown examinations for double-seam cans shall be performed by a qualified individual and the results therefrom shall be recorded at intervals of sufficient frequency on enough containers from each seaming station to ensure maintenance of seam integrity. Such examinations and recordings should be made at intervals not to exceed 4 hours. The results of the teardown examinations shall be recorded and the corrective action taken, if any, shall be noted. (i) Required and optional can seam measurements: ( a ) Micrometer measurement system: ( b ) Seam scope or projector: ( c ) Can double seam terminology: ( 1 ) “Crossover”: The portion of a double seam at the lap. ( 2 ) “Cutover”: A fracture, sharp bend, or break in the metal at the top of the inside portion of the double seam. ( 3 ) “Deadhead”: A seam which is incomplete due to chuck spinning in the countersink. ( 4 ) “Droop”: S… | |||
| 21:21:2.0.1.1.13.5.1.1 | 21 | Food and Drugs | I | B | 113 | PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | E | Subpart E—Production and Process Controls | § 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. (b) Blanching by heat, when required in the preparation of food for canning, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent processing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by cleaning. If the blanched food product is washed before filling, potable water should be used. (c) The filling of containers, either mechanically or by hand, shall be controlled so as to ensure that the filling requirements specified in the scheduled process are met. (d) The exhausting of containers for the removal of air shall be controlled so as to meet the conditions for which the process was designed. Compliance with the requirement may be accomplished by heat exhausting, mechanical exhausting, hot brining, or steam injection. (e) When the maintenance of pH (above 4.6) of a normally low-acid food is a basis for a scheduled process, there shall be careful supervision to ensure that the equilibrium pH of the finished product meets that of the scheduled process. The methodology described in § 114.90 of this chapter should be used. (f) When the scheduled process sets forth critical factors to prevent the growth of microorganisms not destroyed by the thermal process, the factors shall be carefully controlled to ensure that the limits established in the scheduled process are not exceeded. When normally low-acid foods require sufficient solute to permit saf… | ||||
| 21:21:2.0.1.1.13.5.1.2 | 21 | Food and Drugs | I | B | 113 | PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | E | Subpart E—Production and Process Controls | § 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—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | E | Subpart E—Production and Process Controls | § 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. (b) A system for product traffic control in the retort room shall be established to prevent unretorted product from bypassing the retort process. Each retort basket, truck, car, or crate used to hold containers in a retort, or one or more containers therein, shall, if it contains any retorted food product, be plainly and conspicuously marked with a heat-sensitive indicator, or by other effective means that will indicate visually, to thermal processing personnel, those units that have been retorted. A visual check shall be performed to determine whether or not the appropriate change has occurred in the heat-sensitive indicator as a result of retorting for all retort baskets, trucks, cars, or crates, to ensure that each unit of product has been retorted. A record of these checks should be made. (c) The initial temperature of the contents of the containers to be processed shall be accurately determined and recorded with sufficient frequency to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process. For those operations that use water during the filling of the retort or during processing, provision shall be made to ensure that the water will not, before the start of each thermal process, lower the initial temperature of the product below that specified in the scheduled process. The temperature-indicating device used to determine the initial temperature shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards an… | |||
| 21:21:2.0.1.1.13.5.1.4 | 21 | Food and Drugs | I | B | 113 | PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | E | Subpart E—Production and Process Controls | § 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—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS | F | Subpart F—Records and Reports | § 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: (1) Still retorts. Time steam on; time temperature up to processing temperature; time steam off; venting time and temperature to which vented. (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. (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. (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 c… | |||
| 40:40:24.0.1.1.8.1.6.1 | 40 | Protection of Environment | I | D | 113 | PART 113—LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES | A | Subpart A—Oil Storage Facilities | § 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—LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES | A | Subpart A—Oil Storage Facilities | § 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 § 113.4. | ||||
| 40:40:24.0.1.1.8.1.6.3 | 40 | Protection of Environment | I | D | 113 | PART 113—LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES | A | Subpart A—Oil Storage Facilities | § 113.3 Definitions. | EPA | As used in this subpart, the following terms shall have the meanings indicated below: (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. (b) Act means the Federal Water Pollution Control Act, as amended, 33 U.S.C. 1151, et seq. (c) Barrel means 42 United States gallons at 60 degrees Fahrenheit. (d) Belowground storage facility means a tank or other container located other than as defined as “Aboveground”. (e) Discharge includes, but is not limited to any spilling, leaking, pumping, pouring, emitting, emptying or dumping. (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. (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. (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. (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. Additionally, 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—LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES | A | Subpart A—Oil Storage Facilities | § 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: (a) Aboveground storage. (b) Belowground storage. | ||||
| 40:40:24.0.1.1.8.1.6.5 | 40 | Protection of Environment | I | D | 113 | PART 113—LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES | A | Subpart A—Oil Storage Facilities | § 113.5 Exclusions. | EPA | This subpart does not apply to: (a) Those facilities whose average daily oil throughout is more than their fixed oil storage capacity. (b) Vehicles and rolling stock. | ||||
| 40:40:24.0.1.1.8.1.6.6 | 40 | Protection of Environment | I | D | 113 | PART 113—LIABILITY LIMITS FOR SMALL ONSHORE STORAGE FACILITIES | A | Subpart A—Oil Storage Facilities | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.05 | Subpart 113.05—General Provisions | § 113.05-5 Approved equipment. | USCG | If approved equipment is required in this part, that equipment must be specifically approved by the Commandant. Many 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.05 | Subpart 113.05—General Provisions | § 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— (1) Section 4-9-9, Table 1, of ABS Marine Vessel Rules (incorporated by reference; see § 110.10-1 of this subchapter) or the applicable ENV category of Lloyd's Register Type Approval System—Test Specification Number 1 (incorporated by reference; see § 110.10-1 of this subchapter); and (2) IEC 60533:2015 (incorporated by reference; see § 110.10-1 of this subchapter) as appropriate. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.43 | Subpart 113.43—Steering Failure Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.43 | Subpart 113.43—Steering Failure Alarm Systems | § 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: (1) 30 seconds for ordered rudder position changes of 70 degrees; (2) 6.5 seconds for ordered rudder position changes of 5 degrees; and (3) The time period calculated by the following formula for ordered rudder positions changes between 5 degrees and 70 degrees: t = (R/2.76) + 4.64 Where t = maximum time delay in seconds R = ordered rudder change in degrees Where t = maximum time delay in seconds R = ordered rudder change in degrees (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.43 | Subpart 113.43—Steering Failure Alarm Systems | § 113.43-5 Power supply. | USCG | Each steering failure alarm system must be supplied by a circuit that: (a) Is independent of other steering gear system and steering alarm circuits; (b) Is fed from the final emergency power source through the emergency distribution panel in the wheelhouse, if installed; and (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: (1) The current-carrying capacity of the smallest alarm system interconnecting conductors; or (2) The normal load of the system. | ||||
| 46:46:4.0.1.3.17.11.45.1 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.45 | Subpart 113.45—Refrigerated Spaces Alarm Systems | § 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. (b) The alarm activator must be in the refrigerated space at its exit. (c) The audible signal must sound at a manned location. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.50 | Subpart 113.50—Public Address Systems | § 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 § 113.25-1. | |||
| 46:46:4.0.1.3.17.12.45.2 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.50 | Subpart 113.50—Public Address Systems | § 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. (b) The announcing station must be located adjacent to the general emergency alarm contact maker or initiating device on the navigating bridge. (c) There must be a means to silence all other audio distribution systems at the announcing station. (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 § 113.25-5(e)(2). (e) The amplifier, and any device used to produce the general emergency alarm signal, must be provided in duplicate. (f) The power supply must be in accordance with the requirements of §§ 113.25-6 and 113.25-7. (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 § 110.10-1 of this subchapter) requirements. | |||
| 46:46:4.0.1.3.17.12.45.3 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.50 | Subpart 113.50—Public Address Systems | § 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: (a) Survival craft stations, port. (b) Survival craft stations, starboard. (c) Survival craft embarkation stations, port. (d) Survival craft embarkation stations, starboard. (e) Public spaces used for passenger assembly points. (f) Crew quarters. (g) Accommodation spaces and service spaces. | |||
| 46:46:4.0.1.3.17.12.45.4 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.50 | Subpart 113.50—Public Address Systems | § 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. (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. (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— (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 (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.50 | Subpart 113.50—Public Address Systems | § 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. (b) The feeder distribution panel must be in an enclosed space next to the public address system power supply. (c) Each system must have at least one feeder for each vertical fire zone. (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. (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. (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.65 | Subpart 113.65—Whistle Operators | § 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 § 110.10-1 of this subchapter). | |||
| 46:46:4.0.1.3.17.2.45.1 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.10 | Subpart 113.10—Fire and Smoke Detecting and Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.10 | Subpart 113.10—Fire and Smoke Detecting and Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.10 | Subpart 113.10—Fire and Smoke Detecting and Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.10 | Subpart 113.10—Fire and Smoke Detecting and Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.10 | Subpart 113.10—Fire and Smoke Detecting and Alarm Systems | § 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. (b) Batteries. Each battery used in a fire detecting and alarm system must meet Subpart 111.15 of this chapter. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.20 | Subpart 113.20—Automatic Sprinkler Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.20 | Subpart 113.20—Automatic Sprinkler Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 113.25-1 Applicability. | USCG | (a) This subpart, except §§ 113.25-25 and 113.25-30, applies to each manned vessel of over 100 gross tons, except barges, scows, and similar vessels. (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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. (b) Electronic devices used to produce the general emergency alarm signal must meet the requirements of subpart 113.50 of this part. (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 (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). (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 113.25-15 Distribution panels. | USCG | Each distribution panel must: (a) Be watertight; (b) Need a tool to be opened. | ||||
| 46:46:4.0.1.3.17.4.45.13 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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. (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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. (b) Each general alarm contact maker must be marked “GENERAL ALARM” in red letters on a corrosion-resistant plate or on a sign. (c) A contact maker that operates only the general emergency alarm signal in crew quarters, machinery spaces, and work spaces must be marked “CREW ALARM” by the method described in paragraph (b) of this section. (d) Each general emergency alarm signal must be marked “GENERAL ALARM—WHEN EMERGENCY ALARM SIGNAL RINGS GO TO YOUR STATION” in red letters at least 1/2 inch high. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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: (a) Have an automatically charged battery as the power source; (b) Have a manually operated contact maker at the steering station and in the crew accommodation area; and (c) Must meet the requirements of § 113.25.7 and §§ 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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: (a) The number and location of contact makers must be determined by the design, service, and operation of the barge. Contact makers in the primary work area, quarters area, galley and mess area, machinery spaces, and the navigating bridge or control area should be considered. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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: (1) In the navigating bridge; and (2) At the feeder distribution panel if the general alarm power supply is not in or next to the navigating bridge. (b) Tank vessels. Each tank vessel must have a manually operated contact maker for the general emergency alarm system: (1) In the navigating bridge; (2) At the deck officers' quarters farthest from the engineroom; (3) in the engineroom; (4) At the location of the emergency means of stopping cargo transfer required under 33 CFR 155.780; and (5) At the feeder distribution panel if the general alarm power supply is not in or next to the navigating bridge. (c) Mobile offshore drilling units. Each mobile offshore drilling unit must have a manually operated contact maker for the general emergency alarm system: (1) In the main control room; (2) At the drilling console; (3) At the feeder distribution panel; (4) In the navigating bridge, if a navigating bridge is installed; and (5) In a routinely occupied space that is as far as practicable from all other contact makers. (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. (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: (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 (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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. (b) The feeder distribution panel must have overcurrent protection for each zone feeder, but there must be no disconnect switches. (c) The feeder distribution panel must be in an enclosed space next to the general alarm power supply. (d) Each system must have at least one feeder for each vertical fire zone that has general emergency alarm signal. (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. (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. (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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: (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 (b) Be audible in the spaces identified in paragraph (a) of this section with all normally closed doors and accesses closed; and (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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 § 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: (1) Has sufficient intensity above the background lighting that would alert personnel in the space; (2) Is activated whenever the general emergency alarm signal in the space are activated; and (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.25 | Subpart 113.25—General Emergency Alarm Systems | § 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— (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 § 110.10-1 of this subpart) requirements; (b) Have a switch handle that can be maintained in the “on” position; (c) Have the “off” and “on” positions of the operating handle permanently marked; and (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.27 | Subpart 113.27—Engineers' Assistance-Needed Alarm | § 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: (a) Operated from: (1) The engine control room, if the vessel has an engine control room; or (2) The maneuvering platform, if the vessel has no engine control room; (b) Audible in the engineers' accommodation spaces; and (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.30 | Subpart 113.30—Internal Communications | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.30 | Subpart 113.30—Internal Communications | § 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— (1) Be comprised of either fixed or portable equipment; and (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 § 113.30-5. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.30 | Subpart 113.30—Internal Communications | § 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: (1) Navigating bridge. (2) Steering gear room, if outside the engineroom. (3) Alternative steering station if outside of the steering gear room. (4) Engine control room, if the vessel has an engine control room. (5) Maneuvering platform, if the vessel has no engine control room. (6) Control room, if the vessel is a mobile offshore drilling unit. (7) The engineering officers' accommodations, if the vessel is an automated, self-propelled vessel under § 62.50-20(f) of this chapter. (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. (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. (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. (e) Radio and radio direction finder. Communication to the radio and radio direction finder must meet the following requirements: (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 t… | |||
| 46:46:4.0.1.3.17.6.45.4 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.30 | Subpart 113.30—Internal Communications | § 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 § 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 §§ 113.30-5(e) and 113.30-5(h). (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.30 | Subpart 113.30—Internal Communications | § 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. (b) The loss of one component of the system must not disable the rest of the system. (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). (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. (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 § 110.10-1 of this subpart). (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. (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. (h) If two or more voice communication stations are near each other, there must be a means that indicates the station called. (i) Each connection box must meet at least Type 4 or 4X of NEMA 250 or IP 56 of IEC 60529:2013. (j) Voice communication cables must run as close to the fore-and-aft centerline of the vessel as practicable. (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. (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 § 110.10-1 of this subpart). (k) If the communications system uses a sound-powered telephone, the following requirements also apply: (1) Each station except one regulated by paragraph (d) of this section must… | |||
| 46:46:4.0.1.3.17.7.45.1 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 113.35-1 Definitions. | USCG | As used in this subpart: (a) Indicator means an instrument in the engine room to receive and acknowledge engine orders; and (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 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. (b) On a vessel with more than one propulsion engine, each engine must have this system. (c) On a double-ended vessel that has two navigating bridges, this system must be between the engineroom and each navigating bridge. (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. (e) On vessels equipped with pilothouse control, each local control station in the engineroom must have an indicator if: (1) Manual operation from the local control station is an alternative means of control; and (2) The local control station is not immediately adjacent to the engineroom control station; and (3) Reliable voice communication and calling that meets the requirements of § 113.30-5(h) is not provided. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 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. (b) Each engineroom indicator must be capable of acknowledgment of orders. (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. (d) Each telegraph instrument must meet the protection requirements of § 111.01-9 of this chapter. (e) Each system must have an alarm which— (1) Automatically sounds and visually signals a loss of power to the system; (2) Is on the navigating bridge; and (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 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: (1) Operate in synchronism as required in paragraph (b) of this section; or (2) Operate under the control of a transmitter transfer control in accordance with paragraph (c) of this section. (b) All transmitter handles and pointers must operate in synchronism. Where the transmitters are mechanically interlocked to effect synchronous operation, the requirements of § 113.35-13 must be met. (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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.35 | Subpart 113.35—Engine Order Telegraph Systems | § 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 “Navigating Bridge Control” position without positive action by the operator. | |||
| 46:46:4.0.1.3.17.8.45.1 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.37 | Subpart 113.37—Shaft Speed and Thrust Indicators | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.37 | Subpart 113.37—Shaft Speed and Thrust Indicators | § 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. (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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.37 | Subpart 113.37—Shaft Speed and Thrust Indicators | § 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. (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 § 110.10-1 of this subpart) requirements. | |||
| 46:46:4.0.1.3.17.9.45.1 | 46 | Shipping | I | J | 113 | PART 113—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.40 | Subpart 113.40—Rudder Angle Indicator Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.40 | Subpart 113.40—Rudder Angle Indicator Systems | § 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—COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT | 113.40 | Subpart 113.40—Rudder Angle Indicator Systems | § 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. (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 § 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—STANDARD REQUIREMENTS | § 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—STANDARD REQUIREMENTS | § 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 § 112.8(d) or (e) of this subchapter or for further manufacturing purposes as provided in § 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—STANDARD REQUIREMENTS | § 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: (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. (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. (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. (d) Seed cultures are small quantities of standard organisms to be propagated by the recipient to establish a supply for use. (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—STANDARD REQUIREMENTS | § 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. (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. (1) Selection shall be made as follows: (i) Nonviable liquid biological products—either 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. (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. (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. (iv) Representative samples of each serial or subserial in each shipment of imported biological products shall be selected. (2) Comparable samples shall be used by Animal and Plant Health Inspection Service, the licensee, and the permittee for similar tests. (3) When bulk samples of completed … | |||||
| 9:9:1.0.1.5.51.0.74.4 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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—STANDARD REQUIREMENTS | § 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. (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. (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. (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. (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—STANDARD REQUIREMENTS | § 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. (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. (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—STANDARD REQUIREMENTS | § 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. (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. (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. (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 § 113.100 are complied with. (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—STANDARD REQUIREMENTS | § 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: (1) Subjecting the master seed to the applicable requirements prescribed in §§ 113.64, 113.100, 113.200, and 113.300; (2) Testing the Master Seed for immunogenicity in a manner acceptable to the Animal and Plant Health Inspection Service (APHIS); (3) Establishing satisfactory potency for the product in accordance with the following provisions: (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 (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. (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: (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. (2) If the initial test shows … | |||||
| 9:9:1.0.1.5.51.0.74.9 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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. (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 § 113.4. | |||||
| 9:9:1.0.1.5.51.0.75.11 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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 §§ 113.26 and 113.27 are set forth in the United States Pharmacopeia, 19th Edition. (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. (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. (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—STANDARD REQUIREMENTS | § 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. (a) The media to be used shall be as follows: (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. (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. (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. (b) Test procedure: (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 § 113.25(d). (2) Inoculum: (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. (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. (3) Incubation shall be for an observation period of 14 days at 30 °to 35 °C. to test for b… | |||||
| 9:9:1.0.1.5.51.0.75.13 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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. (1) Soybean Casein Digest Medium shall be used. (2) Ten final container samples from each serial and subserial shall be tested. (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. (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 § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 °to 35 °C for 14 days. (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 § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 °to 25 °C for 14 days. (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.… | |||||
| 9:9:1.0.1.5.51.0.75.14 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (a) Media additives provided in this paragraph shall be prepared as follows: (1) DPN-Cysteine Solution: (i) Use Nicotinamide adenine dinucleotide (oxidized) and L-Cysteine hydrochloride. (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 −20 degrees centigrade. (2) Inactivated horse serum—horse serum which has been inactivated at 56 °C for 30 minutes. (b) Heart infusion broth shall be prepared as provided in this paragraph. (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. (2) Add the following: (3) Adjust pH to 7.9 with NaOH, filter sterilize, and dispense 100 ml aliquots into 125 ml flasks and store until needed. (4) Add 2 ml of DPN-Cysteine solution to each 100 ml of broth on day of use. (c) Heart Infusion Agar shall be prepared as provided in this paragraph. (1) Dissolve in 900 ml of purified water by boiling the following: (2) Cool the medium and adjust pH to 7.9 with NaOH. (3) Autoclave the medium. (4) Cool the medium 30 minutes in a 56 °C waterbath. (5) Dissolve 5 grams of yeast autolysate in 100 ml of distilled water, filter sterilize, and add to the medium. (6) Add to the medium: 126 ml of inactivated horse serum 21 ml of DPN-Cysteine solution 525,000 units of Penicillin. Dispense 10 ml aliquots into 60 × 15 mm disposable culture dishes or petri dishes. 126 ml of inactivated horse serum 21 ml of DPN-Cysteine solution 525,000 units of Penicillin. Dispense 10 ml aliquots into 60 × 15 mm disposable culture dishes or pet… | |||||
| 9:9:1.0.1.5.51.0.75.15 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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: (1) Cylindrical weighing bottles with airtight glass stoppers. (2) Vacuum oven equipped with validated thermometer and thermostat. A suitable air-drying device should be attached to the inlet valve. (3) Balance, accurate to 0.1 mg (rated precision ±0.01mg). (4) Desiccator jar equipped with phosphorous pentoxide, silica gel, or equivalent. (5) Desiccated vaccine in original sealed vial. Sample and control should be kept at room temperature in their original airtight containers until use. (b) Test procedure: (1) Thoroughly cleaned and labeled sample-weighing bottles with stoppers should be allowed to dry at 60 ±3 °C under vacuum at less than 2.5 kPa. (i) Transfer hot bottles and stoppers into the desiccator and allow to cool to room temperature. (ii) After bottles have cooled, insert stoppers and weigh and record the weights of the bottles as “A.” (iii) Return weighing bottles to the desiccator. (2) Remove the sample container seal. (i) Using a spatula, break up the sample plug and transfer the required amount of sample to the previously tared weighing bottle. (ii) Insert the stopper and weigh and record the weights of the weighing bottles as “B.” (3) Place the weighing bottle with the stopper at an angle in the vacuum oven. Se… | |||||
| 9:9:1.0.1.5.51.0.75.16 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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. (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 °C. (c) Transfers shall be made to either MacConkey agar or Salmonella-Shigella agar, incubated for 18-24 hours and examined. (d) If no growth typical of Salmonella is noted, the plates shall be incubated an additional 18-24 hours and again examined. (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—STANDARD REQUIREMENTS | § 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. (a) Propagation of contaminating lymphoid leukosis viruses, if present, shall be done in chick embryo cell cultures. (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. (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. (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. (4) The cell cultures sha… | |||||
| 9:9:1.0.1.5.51.0.75.18 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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 °C for at least 7 days. (b) If colonies are identified as Brucella, the biological product is unsatisfactory. (c) If colonies suspicious of Brucella are observed but cannot be identified as a Brucella species, either (1) The biological product shall be regarded as unsatisfactory and destroyed; or (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—STANDARD REQUIREMENTS | § 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. (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. (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. (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. (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. (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. (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 attributa… | |||||
| 9:9:1.0.1.5.51.0.75.20 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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. (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. (1) Test five uninoculated embryos of the same age and from the same flock as those used for the test as negative controls. (2) Test an allantoic fluid sample of Newcastle disease virus as a positive control. (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. (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. (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—STANDARD REQUIREMENTS | § 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. (a) Bulk or final container samples of completed product from each serial shall be tested. (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. (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. (2) Rehydrate at least two vials of the vaccine with the same volume of sterile purified water and pool the contents. (3) Neutralize to remove other fractions, if necessary. (4) Hold the two pools of vaccine at room temperature (20 °to 25 °C) for 2 hours. The holding period shall begin when rehydration is completed. (5) Titrate the virus(es) in each pool of vaccine as provided in the filed Outline of Production or an applicable standard requirement. (6) Compare respective titers. (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. (e) If the product is unsatisfactory in the first test, one retest to rule out faulty techniques may be conducted using f… | |||||
| 9:9:1.0.1.5.51.0.75.22 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (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. (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. (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 2 ). Twenty birds may be used for each route or combination of routes. (d) At least five birds shall be isolated as control birds. (e) All birds shall be observed for 21 days for signs of septicemic diseases, respiratory diseases, or other pathologic conditions. (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—STANDARD REQUIREMENTS | § 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. (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. (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. (c) After neutralization, 0.2 ml of the vaccine-serum mixture shall be inoculated into each of at least 20 fully susceptible chicken embryos. (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. (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. (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—STANDARD REQUIREMENTS | § 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. (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. (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—STANDARD REQUIREMENTS | § 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. (a) The cat safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety. (1) The test animals shall be determined to be susceptible to the virus under test as follows: (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. (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. (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. (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. (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. (b) The cat safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release. (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. (2) If unfavorable reac… | |||||
| 9:9:1.0.1.5.51.0.75.26 | 9 | Animals and Animal Products | I | E | 113 | PART 113—STANDARD REQUIREMENTS | § 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. (a) The dog safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety. (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. (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. (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. (b) The dog safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release. (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. (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—STANDARD REQUIREMENTS | § 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. (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. (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—STANDARD REQUIREMENTS | § 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. (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. (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—STANDARD REQUIREMENTS | § 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. (a) The yolk sac of 6-day-old chicken embryos shall be injected. Three groups of 10 embryos shall be used sequentially. (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. (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. (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. (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. |
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chapter TEXT,
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