cfr_sections
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12 rows where agency = "FSIS" and part_number = 431 sorted by section_id
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9:9:2.0.2.4.45.0.40.1 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.1 Definitions. | FSIS | Abnormal container. A container with any sign of swelling or product leakage or any evidence that the contents of the unopened container may be spoiled. Acidified low acid product. A canned product which has been formulated or treated so that every component of the finished product has a pH of 4.6 or lower within 24 hours after the completion of the thermal process unless data are available from the establishment's processing authority demonstrating that a longer time period is safe. Bleeders. Small orifices on a retort through which steam, other gasses, and condensate are emitted from the retort throughout the entire thermal process. Canned product. A meat or poultry food product with a water activity above 0.85 which receives a thermal process either before or after being packed in a hermetically sealed container. Unless otherwise specified, the term “product” as used in this part means “canned product.” Closure technician. The individual(s) identified by the establishment as being trained to perform specific container integrity examinations as required by this part and designated by the establishment to perform such examinations. Code lot. All production of a particular product in a specific size container marked with a specific container code. Come-up time. The elapsed time, including venting time (if applicable), between the introduction of the heating medium into a closed retort and the start of process timing. Critical factor. Any characteristic, condition or aspect of a product, container, or procedure that affects the adequacy of the process schedule. Critical factors are established by processing authorities. Headspace. That portion of a container not occupied by the product. (1) Gross headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the top edge of the container ( i.e., the flange of an unsealed can, the top of the double seam on a sealed can, or the top edge of an unsealed jar). (2) Net headspace. … | ||||||
| 9:9:2.0.2.4.45.0.40.10 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.10 Finished product inspection. | FSIS | (a) Finished product inspections must be handled according to: (1) An HACCP plan for canned product that addresses hazards associated with microbiological contamination; (2) An FSIS-approved total quality control system; (3) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or (4) Paragraph (b) of this section. (b) Procedures for handling finished product inspections where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations. (1) Incubation of shelf stable canned produc t—(i) Incubator. The establishment must provide incubation facilities which include an accurate temperature/time recording device, an indicating temperature device, a means for the circulation of the air inside the incubator to prevent temperature variations, and a means to prevent unauthorized entry into the facility. The Program is responsible for the security of the incubator. (ii) Incubation temperature. The incubation temperature must be maintained at 95±5 °F (35±2.8 °C). If the incubation temperature falls below 90 °F (or 32 °C) or exceeds 100 °F (or 38 °C) but does not reach 103 °F (or 39.5 °C), the incubation temperature must be adjusted within the required range and the incubation time extended for the time the sample containers were held at the deviant temperature. If the incubation temperature is at or above 103 °F (or 39.5 °C) for more than 2 hours, the incubation test(s) must be terminated, the temperature lowered to within the required range, and new sample containers incubated for the required time. (iii) Product requiring incubation. Shelf stable product requiring incubation includes: (A) Low acid products as defined in § 431.1; and (B) Acidified low acid products as defined in § 431.1. (iv) Incubation samples… | ||||||
| 9:9:2.0.2.4.45.0.40.11 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.11 Personnel and training. | FSIS | All operators of thermal processing systems specified in § 431.6 and container closure technicians must be under the direct supervision of a person who has successfully completed a school of instruction that is generally recognized as adequate for properly training supervisors of canning operations. | ||||||
| 9:9:2.0.2.4.45.0.40.12 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.12 Recall procedure. | FSIS | Establishments must prepare and maintain a current procedure for the recall of all canned product covered by this subpart. Upon request, the recall procedure must be made available to Program employees for review. | ||||||
| 9:9:2.0.2.4.45.0.40.2 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.2 Containers and closures. | FSIS | (a) Examination and handling of empty containers. (1) Empty containers, closures, and flexible pouch roll stock must be evaluated by the establishment to ensure that they are free of structural defects and damage that may affect product or container integrity. Such an examination should be based on a statistical sampling plan. (2) All empty containers, closures, and flexible pouch roll stock must be stored, handled, and conveyed in such a manner that will prevent damage that could affect the hermetic condition of the sealed container. (3) Just before filling, rigid containers must be cleaned to prevent incorporation of foreign matter into the finished product. Closures, semirigid containers, preformed flexible pouches, and flexible pouch roll stock contained in original wrappings do not need to be cleaned before use. (b) Closure examinations for rigid containers (cans) —(1) Visual examinations. A closure technician must visually examine the double seams formed by each closing machine head. When seam defects ( e.g., cutovers, sharpness, knocked down flanges, false seams, droops) are observed, necessary corrective actions, such as adjusting or repairing the closing machine, must be taken. In addition to the double seams, the entire container must be examined for product leakage or obvious defects. A visual examination must be performed on at least one container from each closing machine head, and the observations, along with any corrective actions, must be recorded. Visual examinations must be conducted with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations must be made by the closure technician at the beginning of production, immediately following every jam in the closing machine and after closing machine adjustment (including adjustment for changes in container size). (2) Teardown examinations. Teardown examinations of double seams formed by each closing machine head must be performed … | ||||||
| 9:9:2.0.2.4.45.0.40.3 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.3 Thermal processing. | FSIS | (a) Process schedules. Prior to the processing of canned product for distribution in commerce, an establishment must have a process schedule (as defined in § 431.1) for each canned meat or poultry product to be packed by the establishment. (b) Source of process schedules. (1) Process schedules used by an establishment must be developed or determined by a processing authority. (2) Any change in product formulation, ingredients, or treatments that are not already incorporated in a process schedule and that may adversely affect either the product heat penetration profile or sterilization value requirements must be evaluated by the establishment's processing authority. If it is determined that any such change adversely affects the adequacy of the process schedule, the processing authority must amend the process schedule accordingly. (3) Complete records concerning all aspects of the development or determination of a process schedule, including any associated incubation tests, must be made available by the establishment to the Program employee upon request. (c) Submittal of process information. (1) Prior to the processing of canned product for distribution in commerce, the establishment must provide the inspector at the establishment with a list of the process schedules (including alternate schedules) along with any additional applicable information, such as the retort come-up operating procedures and critical factors. (2) Letters or other written communications from a processing authority recommending all process schedules must be maintained on file by the establishment. Upon request by Program employees, the establishment must make available such letters or written communications (or copies thereof). If critical factors are identified in the process schedule, the establishment must provide the inspector with a copy of the procedures for measuring, controlling, and recording these factors, along with the frequency of such measurements, to ensure that the critical factors remain within the limits used to es… | ||||||
| 9:9:2.0.2.4.45.0.40.4 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.4 Critical factors and the application of the process schedule. | FSIS | Critical factors specified in the process schedule must be measured, controlled, and recorded by the establishment to ensure that these factors remain within the limits used to establish the process schedule. Examples of factors that are often critical to process schedule adequacy may include: (a) General. (1) Maximum fill-in weight or drained weight; (2) Arrangement of pieces in the container; (3) Container orientation during thermal processing; (4) Product formulation; (5) Particle size; (6) Maximum thickness for flexible containers, and to some extent semirigid containers, during thermal processing; (7) Maximum pH; (8) Percent salt; (9) Ingoing (or formulated) nitrite level (ppm); (10) Maximum water activity; and (11) Product consistency or viscosity. (b) Continuous rotary and batch agitating retorts. (1) Minimum headspace; and (2) Retort reel speed. (c) Hydrostatic retorts. (1) Chain or conveyor speed. (2) [Reserved] (d) Steam/air retorts. (1) Steam/air ratio; and (2) Heating medium flow rate. | ||||||
| 9:9:2.0.2.4.45.0.40.5 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.5 Operations in the thermal processing area. | FSIS | (a) Posting of processes. Process schedules (or operating process schedules) for daily production, including minimum initial temperatures and operating procedures for thermal processing equipment, must be posted in a conspicuous place near the thermal processing equipment. Alternatively, such information must be available to the thermal processing system operator and the inspector. (b) Process indicators and retort traffic control. A system for product traffic control must be established to prevent product from bypassing the thermal processing operation. Each basket, crate, or similar vehicle containing unprocessed product, or at least one visible container in each vehicle, must be plainly and conspicuously marked with a heat sensitive indicator that will visually indicate whether such unit has been thermally processed. Exposed heat sensitive indicators attached to container vehicles must be removed before such vehicles are refilled with unprocessed product. Container loading systems for crateless retorts must be designed to prevent unprocessed product from bypassing the thermal processing operation. (c) Initial temperature. The initial temperature of the contents of the coldest container to be processed must be determined and recorded by the establishment at the time the processing cycle begins to assure that the temperature of the contents of every container to be processed is not lower than the minimum initial temperature specified in the process schedule. Thermal processing systems which subject the filled and sealed containers to water at any time before process timing begins must be operated to assure that such water will not lower the temperature of the product below the minimum initial temperature specified in the process schedule. (d) Timing devices. Devices used to time applicable thermal processing operation functions or events, such as process schedule time, come-up time, and retort venting, must be accurate to assure that all such functions or events are achieved. Pocket watches and wrist … | ||||||
| 9:9:2.0.2.4.45.0.40.6 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.6 Equipment and procedures for heat processing systems. | FSIS | (a) Instruments and controls common to different thermal processing systems —(1) Indicating temperature devices. Each retort must be equipped with at least one indicating temperature device that measures the actual temperature within the retort. The indicating temperature device, not the temperature/time recording device, must be used as the reference instrument for indicating the process temperature. (i) Mercury-in-glass thermometers. A mercury-in-glass thermometer must have divisions that are readable to 1 °F (or 0.5 °C) and whose scale contains not more than 17 °F/inch (or 4.0 °C/cm) of graduated scale. Each mercury-in-glass thermometer must be tested for accuracy against a known accurate standard upon installation and at least once a year to ensure its accuracy. Records that specify the date, standard used, test method, and the person or testing authority performing the test must be maintained on file by the establishment and made available to Program employees. A mercury-in-glass thermometer that has a divided mercury column or that cannot be adjusted to the standard must be repaired and tested for accuracy before further use, or replaced. (ii) Other devices. Temperature-indicating devices, such as resistance temperature detectors, used in lieu of mercury-in-glass thermometers, must meet known, accurate standards for such devices when tested for accuracy. The records of such testing must be available to FSIS program employees. (2) Temperature/time recording devices. Each thermal processing system must be equipped with at least one temperature/time recording device to provide a permanent record of temperatures within the thermal processing system. This recording device may be combined with the steam controller and may be a recording/controlling instrument. When compared to the known accurate indicating temperature device, the recording accuracy must be equal to or better than 1 °F (or 0.5 °C) at the process temperature. The temperature recording chart should be adjusted to agree with, but must … | ||||||
| 9:9:2.0.2.4.45.0.40.7 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.7 Processing and production records. | FSIS | At least the following processing and production information must be recorded by the establishment: Date of production; product name and style; container code; container size and type; and the process schedule, including the minimum initial temperature. Measurements made to satisfy the requirements of § 431.4 regarding the control of critical factors must be recorded. In addition, where applicable, the following information and data must also be recorded: (a) Processing in steam —(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or the number of retort crates per retort load, product initial temperature, time steam on, the time and temperature vent closed, the start of process timing, time steam off, and the actual processing time. The indicating temperature device and the temperature recorder must be read at the same time at least once during process timing and the observed temperatures recorded. (2) Batch agitating retorts. In addition to recording the information required for batch still steam retorts in paragraph (a)(1) of this section, record the functioning of the condensate bleeder(s) and the retort or reel speed. (3) Continuous rotary retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent closed, time process temperature reached, the time the first can enters and the time the last can exits the retort. The retort or reel speed must be determined and recorded at intervals not to exceed 4 hours. Readings of the indicating temperature device(s) and temperature recorder(s) must be made and recorded at the time the first container enters the retort and thereafter with sufficient frequency to ensure compliance with the process schedule. These observations should be made and recorded at intervals not exceeding 30 minutes of continuous retort operation. Functioning of the condensate bleeder(s) must be observed … | ||||||
| 9:9:2.0.2.4.45.0.40.8 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.8 Record review and maintenance. | FSIS | (a) Process records. Charts from temperature/time recording devices must be identified by production date, container code, processing vessel number or other designation, and other data as necessary to enable correlation with the records required in § 431.7. Each entry on a record must be made at the time the specific event occurs, and the recording individual must sign or initial each record form. No later than 1 working day after the actual process, the establishment must review all processing and production records to ensure completeness and to determine if all product received the process schedule. All records, including the temperature/time recorder charts and critical factor control records, must be signed or initialed and dated by the person conducting the review. All processing and production records required in this subpart must be made available to Program employees for review. (b) Automated process monitoring and recordkeeping. Automated process monitoring and recordkeeping systems must be designed and operated in a manner that will ensure compliance with the applicable requirements of § 431.7. (c) Container closure records. Written records of all container closure examinations must specify the container code, the date and time of container closure examination, the measurement(s) obtained, and any corrective actions taken. Records must be signed or initialed by the container closure technician and must be reviewed and signed by the establishment within 1 working day after the actual production to ensure that the records are complete and that the closing operations have been properly controlled. All container closure examination records required in this subpart must be made available to Program employees for review. (d) Distribution of product. Records must be maintained by the establishment identifying initial distribution of the finished product to facilitate, if necessary, the segregation of specific production lots that may have been contaminated or are otherwise unsound for their intended… | ||||||
| 9:9:2.0.2.4.45.0.40.9 | 9 | Animals and Animal Products | III | E | 431 | PART 431—THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS | § 431.9 Deviations in processing. | FSIS | (a) Whenever the actual process is less than the process schedule or when any critical factor does not comply with the requirements for that factor as specified in the process schedule, it must be considered a deviation in processing. (b) Deviations in processing (or process deviations) must be handled according to: (1) A HACCP plan for canned product that addresses hazards associated with microbial contamination; or, (2) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or (3) Paragraph (c) of this section. (c) Procedures for handling process deviations where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations. (1) Deviations identified in-process. If a deviation is noted at any time before the completion of the intended process schedule, the establishment must: (i) Immediately reprocess the product using the full process schedule; or (ii) Use an appropriate alternate process schedule provided such a process schedule has been established in accordance with § 431.3(a) and (b) and is filed with the inspector in accordance with § 431.3(c); or (iii) Hold the product involved and have the deviation evaluated by a processing authority to assess the safety and stability of the product. Upon completion of the evaluation, the establishment must provide the inspector the following: (A) A complete description of the deviation along with all necessary supporting documentation; (B) A copy of the evaluation report; and (C) A description of any product disposition actions, either taken or proposed. (iv) Product handled in accordance with paragraph (c)(1)(iii) of this section must not be shipped from the establishment until the Program has reviewed all of the information submitted and approved the product dis… |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);