cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
8 rows where part_number = 114 and title_number = 21 sorted by section_id
This data as json, CSV (advanced)
Suggested facets: subpart, subpart_name, amendment_citations
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:2.0.1.1.14.1.1.1 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | A | Subpart A—General Provisions | § 114.3 Definitions. | FDA | [44 FR 16235, Mar. 16, 1979, as amended at 61 FR 14245, Apr. 1, 1996] | For the purposes of this part, the following definitions apply. (a) Acid foods means foods that have a natural pH of 4.6 or below. (b) Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (a w ) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, “pickles” or “pickled ______.” Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this part. (c) Lot means the product produced during a period indicated by a specific code. (d) Low-acid foods means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (a w ) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods. (e) Scheduled process means the process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority. (f) Shall is used to state mandatory requirements. (g) Should is used to state recommended or advisory procedures or to identify recommended equipment. (h) Water activity (a w ) is a measure of the free moisture in a product and is the quotient of the water vapor press… | |||
| 21:21:2.0.1.1.14.1.1.2 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | A | Subpart A—General Provisions | § 114.5 Current good manufacturing practice. | FDA | [80 FR 56144, Sept. 17, 2015] | The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in parts 110 and 117 of this chapter, apply in determining whether an article of acidified food is adulterated: (a) Within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it has been manufactured under such conditions that it is unfit for food; or (b) Within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. | |||
| 21:21:2.0.1.1.14.1.1.3 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | A | Subpart A—General Provisions | § 114.10 Personnel. | FDA | All operators of processing and packaging systems shall be under the operating supervisions of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food-protection principles, personal hygiene and plant sanitation practices, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction. The Commissioner will consider students who have satisfactorily completed the required portions of the courses presented under § 108.35 and part 113 of this chapter before March 16, 1979, to be in compliance with the requirement of this section. | ||||
| 21:21:2.0.1.1.14.3.1.1 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.80 Processes and controls. | FDA | (a) Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard. (1) Acidified foods shall be so manufactured, processed, and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the scheduled process. Acidified foods shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Permitted preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance (in lieu of thermal processing). (2) Sufficient control, including frequent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Measurement of acidity of foods in-process may be made by potentiometric methods, titratable acidity, or colorimetric methods. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by titration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suitable method. Special care should be taken when food ingredients have been subjected to lye, lime, or similar high pH materials. (3) Procedures for acidification to attain acceptable equilibrium pH levels in the final food include, but are not limited to, the following: (i) Blanching of the food ingredients in acidified aqueous solutions. (ii) Immersion of the blanched food in acid solutions. Although immersion of food in an acid solution is a sa… | ||||
| 21:21:2.0.1.1.14.3.1.2 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.83 Establishing scheduled processes. | FDA | The scheduled process shall be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods. | ||||
| 21:21:2.0.1.1.14.3.1.3 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.89 Deviations from scheduled processes. | FDA | Whenever any process operation deviates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the commercial processor of the acidified food shall either: (a) Fully reprocess that portion of the food by a process established by a competent processing authority as adequate to ensure a safe product; (b) thermally process it as a low-acid food under part 113 of this chapter; or (c) set aside that portion of the food involved for further evaluation as to any potential public health significance. The 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 the evaluation demonstrates that the food has undergone a process that has rendered it safe, the food set aside shall either be fully reprocessed to render it safe, or be destroyed. A record shall be made of the procedures used in the evaluation and the results. Either upon completion of full reprocessing and the attainment of a safe food, or after the determination that no significant potential for public health hazard exists, that portion of the food involved may be shipped in normal distribution. Otherwise, the portion of the food involved shall be destroyed. | ||||
| 21:21:2.0.1.1.14.3.1.4 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.90 Methodology. | FDA | [44 FR 16235, Mar. 16, 1979, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 5609, Feb. 14, 1984; 54 FR 24892, June 12, 1989; 63 FR 14035, Mar. 24, 1998] | Methods that may be used to determine pH or acidity for acidified foods include, but are not limited to, the following: (a) Potentiometric method for the determination of pH —(1) Principles. The term “pH” is used to designate the intensity or degree of acidity. The value of pH, the logarithm of the reciprocal of the hydrogen ion concentration in solution, is determined by measuring the difference in potential between two electrodes immersed in a sample solution. A suitable system consists of a potentiometer, a glass electrode, and a reference electrode. A precise pH determination can be made by making an electromotive force (emf) measurement of a standard buffer solution whose pH is known, and then comparing that measurement to an emf measurement of a sample of the solution to be tested. (2) Instruments. The primary instrument for use in pH determination is the pH meter or potentiometer. For most work, an instrument with a direct-reading pH scale is necessary. Battery and line-operated instruments are available commercially. If the line voltage is unstable, line-operated instruments should be fitted with voltage regulators to eliminate drifting of meter-scale readings. Batteries should be checked frequently to ensure proper operation of battery operated instruments. An instrument using an expanded unit scale or a digital readout system is preferred since it allows more precise measurements. (3) Electrodes. The typical pH meter is equipped with a glass membrane electrode and a reference electrode or a single probe combination electrode. Various types of electrodes designed for specific uses are available. The most commonly used reference electrode is the calomel electrode, which incorporates a salt bridge filled with saturated potassium chloride solution. (i) Care and use of electrodes. Calomel electrodes should be kept filled with saturated potassium chloride solution or other solution specified by the manufacturer because they may become damaged if they are allowed to dry out. For best results, elec… | |||
| 21:21:2.0.1.1.14.4.1.1 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | F | Subpart F—Records and Reports | § 114.100 Records. | FDA | [44 FR 16235, Mar. 16, 1979, as amended at 65 FR 56479, Sept. 19, 2000] | (a) Records shall be maintained of examinations of raw materials, packaging materials, and finished products, and of suppliers' guarantees or certifications that verify compliance with Food and Drug Administration regulations and guidance documents or action levels. (b) Processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, shall be maintained and shall contain sufficient additional information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production. (c) All departures from scheduled processes having a possible bearing on public health or the safety of the food shall be noted and the affected portion of the product identified; these departures shall be recorded and made the subject of a separate file (or log identifying the appropriate data) delineating them, the action taken to rectify them, and the disposition of the portion of the product involved. (d) Records shall be maintained identifying initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use. (e) Copies of all records provided for in paragraphs (b), (c), and (d) of this section shall be retained at the processing plant or other reasonably accessible location for a period of 3 years from the date of manufacture. |
Advanced export
JSON shape: default, array, newline-delimited, object
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);