cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
360 rows where part_number = 173 sorted by section_id
This data as json, CSV (advanced)
Suggested facets: title_name, subchapter, part_name, subpart, subpart_name
part_number 1
- 173 · 360 ✖
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:3.0.1.1.4.1.1.1 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.5 Acrylate-acrylamide resins. | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 46 FR 30494, June 9, 1981] | Acrylate-acrylamide resins may be safely used in food under the following prescribed conditions: (a) The additive consists of one of the following: (1) Acrylamide-acrylic acid resin (hydrolyzed polyacrylamide) is produced by the polymerization of acrylamide with partial hydrolysis, or by copolymerization of acrylamide and acrylic acid, with the greater part of the polymer being composed of acrylamide units. (2) Sodium polyacrylate-acrylamide resin is produced by the polymerization and subsequent hydrolysis of acrylonitrile in a sodium silicate-sodium hydroxide aqueous solution, with the greater part of the polymer being composed of acrylate units. (b) The additive contains not more than 0.05 percent of residual monomer calculated as acrylamide. (c) The additive is used or intended for use as follows: (1) The additive identified in paragraph (a)(1) of this section is used as a flocculent in the clarification of beet sugar juice and liquor or cane sugar juice and liquor or corn starch hydrolyzate in an amount not to exceed 5 parts per million by weight of the juice or 10 parts per million by weight of the liquor or the corn starch hydrolyzate. (2) The additive identified in paragraph (a)(2) of this section is used to control organic and mineral scale in beet sugar juice and liquor or cane sugar juice and liquor in an amount not to exceed 2.5 parts per million by weight of the juice or liquor. | |||
| 21:21:3.0.1.1.4.1.1.10 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.60 Dimethylamine-epichlorohydrin copolymer. | FDA | [48 FR 37614, Aug. 19, 1983, as amended at 54 FR 24897, June 12, 1989; 88 FR 17722, Mar. 24, 2023] | Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0) may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is produced by copolymerization of dimethylamine and epichlorohydrin in which not more than 5 mole-percent of dimethylamine may be replaced by an equimolar amount of ethylenediamine, and in which the mole ratio of total amine to epichlorohydrin is approximately 1:1. (b) The additive meets the following specifications: (1) The nitrogen content of the copolymer is 9.4 to 10.8 weight percent on a dry basis. (2) A 50-percent-by-weight aqueous solution of the copolymer has a minimum viscosity of 175 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by another equivalent method). (3) The additive contains not more than 1,000 parts per million of 1,3-dichloro-2-propanol and not more than 10 parts per million epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol content is determined by an analytical method entitled “The Determination of Epichlorohydrin and 1,3-Dichloro-2-Propanol in Dimethylamine-Epichlorohydrin Copolymer,” which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (4) Heavy metals (as Pb), 2 parts per million maximum. (5) Arsenic (as As), 2 parts per million maximum. (c) The food additive is used as a decolorizing agent and/or flocculant in the clarification of refinery sugar liquors and juices. It is added only at the defecation/clarification stage of sugar liquor refining at a concentration not to exceed 150 parts per… | |||
| 21:21:3.0.1.1.4.1.1.11 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.65 Divinylbenzene copolymer. | FDA | [50 FR 61, Jan. 2, 1985, as amended at 88 FR 17722, Mar. 24, 2023] | Divinylbenzene copolymer may be used for the removal of organic substances from aqueous foods under the following prescribed conditions: (a) The copolymer is prepared in appropriate physical form and is derived by the polymerization of a grade of divinylbenzene which comprises at least 79 weight-percent divinylbenzene, 15 to 20 weight-percent ethylvinylbenzene, and no more than 4 weight-percent nonpolymerizable impurities. (b) In accordance with the manufacturer's directions, the copolymer described in paragraph (a) of this section is subjected to pre-use extraction with a water soluble alcohol until the level of divinylbenzene in the extract is less than 50 parts per billion as determined by a method titled, “The Determination of Divinylbenzene in Alcohol Extracts of Amberlite XAD-4,” which is incorporated by reference. Copies of this method are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The copolymer is then treated with water according to the manufacturer's recommendation to remove the extraction solvent to guarantee a food-grade purity of the resin at the time of use, in accordance with current good manufacturing practice. (c) The temperature of the aqueous food stream contacting the polymer is maintained at 79.4 °C (175 °F) or less. (d) The copolymer may be used in contact with food only of Types I, II, and VI-B (excluding carbonated beverages) described in table 1 of paragraph (c) of § 176.170 of this chapter. | |||
| 21:21:3.0.1.1.4.1.1.12 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.70 Chloromethylated aminated styrene-divinylbenzene resin. | FDA | [50 FR 29209, July 18, 1985] | Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg. No. 60177-39-1) may be safely used in food in accordance with the following prescribed conditions: (a) The additive is an aqueous dispersion of styrene-divinylbenzene copolymers, first chloromethylated then aminated with trimethylamine, having an average particle size of not more than 2.0 microns. (b) The additive shall contain no more than 3.0 percent nonvolatile, soluble extractives when tested as follows: One hundred grams of the additive is centrifuged at 17,000 r/min for 2 hours. The resulting clear supernatant is removed from the compacted solids and concentrated to approximately 10 grams on a steam bath. The 10-gram sample is again centrifuged at 17,000 r/min for 2 hours to remove any residual insoluble material. The supernatant from the second centrifugation is then removed from any compacted solids and dried to constant residual weight using a steam bath. The percent nonvolatile solubles is obtained by dividing the weight of the dried residue by the weight of the solids in the original resin dispersion. (c) The additive is used as a decolorizing and clarification agent for treatment of refinery sugar liquors and juices at levels not to exceed 500 parts of additive solids per million parts of sugar solids. | |||
| 21:21:3.0.1.1.4.1.1.13 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.73 Sodium polyacrylate. | FDA | [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988, as amended at 88 FR 17722, Mar. 24, 2023] | Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in food in accordance with the following prescribed conditions: (a) The additive is produced by the polymerization of acrylic acid and subsequent hydrolysis of the polyacrylic acid with an aqueous sodium hydroxide solution. As determined by a method entitled “Determination of Weight Average and Number Average Molecular Weight of Sodium Polyacrylate,” which is incorporated by reference in accordance with 5 U.S.C. 552(a), the additive has— (1) A weight average molecular weight of 2,000 to 2,300; and (2) A weight average molecular weight to number average molecular weight ratio of not more than 1.3. Copies of the method are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) The additive is used to control mineral scale during the evaporation of beet sugar juice or cane sugar juice in the production of sugar in an amount not to exceed 3.6 parts per million by weight of the raw juice. | |||
| 21:21:3.0.1.1.4.1.1.14 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.75 Sorbitan monooleate. | FDA | [51 FR 11720, Apr. 7, 1986] | Sorbitan monooleate may be safely used in accordance with the following prescribed conditions: (a) The additive is produced by the esterification of sorbitol with commercial oleic acid. (b) It meets the following specifications: (1) Saponification number, 145-160. (2) Hydroxyl number, 193-210. (c) The additive is used or intended for use as follows: (1) As an emulsifier in polymer dispersions that are used in the clarification of cane or beet sugar juice or liquor in an amount not to exceed 7.5 percent by weight in the final polymer dispersion. (2) The additive is used in an amount not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in sugar liquor. | |||
| 21:21:3.0.1.1.4.1.1.2 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.10 Modified polyacrylamide resin. | FDA | Modified polyacrylamide resin may be safely used in food in accordance with the following prescribed conditions: (a) The modified polyacrylamide resin is produced by the copolymerization of acrylamide with not more than 5-mole percent β-methacrylyloxyethy-ltrimethylammonium methyl sulfate. (b) The modified polyacrylamide resin contains not more than 0.05 percent residual acrylamide. (c) The modified polyacrylamide resin is used as a flocculent in the clarification of beet or cane sugar juice in an amount not exceeding 5 parts per million by weight of the juice. (d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to the other information required by the act, adequate directions to assure use in compliance with paragraph (c) of this section. | ||||
| 21:21:3.0.1.1.4.1.1.3 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.20 Ion-exchange membranes. | FDA | Ion-exchange membranes may be safely used in the processing of food under the following prescribed conditions: (a) The ion-exchange membrane is prepared by subjecting a polyethylene base conforming to § 177.1520 of this chapter to polymerization with styrene until the polystyrene phase of the base is not less than 16 percent nor more than 30 percent by weight. The base is then modified by reaction with chloromethyl methyl ether, and by subsequent amination with trimethylamine, dimethylamine, diethylenetriamine, or dimethylethanolamine. (b) The ion-exchange membrane is manufactured so as to comply with the following extraction limitations when subjected to the described procedure: Separate square-foot samples of membrane weighing approximately 14 grams each are cut into small pieces and refluxed for 4 hours in 150 cubic centimeters of the following solvents: Distilled water, 5 percent acetic acid, and 50 percent alcohol. Extraction from each sample will not exceed 0.4 percent by weight of sample. (c) The ion-exchange membrane will be used in the production of grapefruit juice to adjust the ratio of citric acid to total solids of the grapefruit juice produced. | ||||
| 21:21:3.0.1.1.4.1.1.4 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.21 Perfluorinated ion exchange membranes. | FDA | [59 FR 15623, Apr. 4, 1994] | Substances identified in paragraph (a) of this section may be safely used as ion exchange membranes intended for use in the treatment of bulk quantities of liquid food under the following prescribed conditions: (a) Identity. The membrane is a copolymer of ethanesulfonyl fluoride, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, with tetrafluoroethylene that has been subsequently treated to hydrolyze the sulfonyl fluoride group to the sulfonic acid. The Chemical Abstracts Service name of this polymer is ethanesulfonic acid, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, polymer with tetrafluoroethane (CAS Reg. No. 31175-20-9). (b) Optional adjuvant substances. The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymer. These optional adjuvant substances may include substances used in accordance with § 174.5 of this chapter. (c) Conditions of use. (1) Perfluorinated ion exchange membranes described in paragraph (a) of this section may be used in contact with all types of liquid foods at temperatures not exceeding 70° (158 °F). (2) Maximum thickness of the copolymer membrane is 0.007 inch (0.017 centimeter). (3) Perfluorinated ion exchange membranes shall be maintained in a sanitary manner in accordance with current good manufacturing practice so as to prevent microbial adulteration of food. (4) To assure their safe use, perfluorinated ionomer membranes shall be thoroughly cleaned prior to their first use in accordance with current good manufacturing practice. | |||
| 21:21:3.0.1.1.4.1.1.5 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.25 Ion-exchange resins. | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 46 FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR 14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016; 88 FR 17722, Mar. 24, 2023] | Ion-exchange resins may be safely used in the treatment of food under the following prescribed conditions: (a) The ion-exchange resins are prepared in appropriate physical form, and consist of one or more of the following: (1) Sulfonated copolymer of styrene and divinylbenzene. (2) Sulfonated anthracite coal meeting the requirements of ASTM method D388-38, Class I, Group 2, “Standard Specifications for Classification of Coal by Rank,” which is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (3) Sulfite-modified cross-linked phenol-formaldehyde, with modification resulting in sulfonic acid groups on side chains. (4) Methacrylic acid-divinylbenzene copolymer. (5) Cross-linked polystyrene, first chloromethylated then aminated with trimethylamine, dimethylamine, di-ethylenetriamine, or dimethylethanol-amine. (6) Diethylenetriamine, triethylene-tetramine, or tetraethylenepentamine cross-linked with epichlorohydrin. (7) Cross-linked phenol-formaldehyde activated with one or both of the following: Triethylene tetramine and tetraethylenepentamine. (8) Reaction resin of formaldehyde, acetone, and tetraethylenepentamine. (9) Completely hydrolyzed copolymers of methyl acrylate and divinylbenzene. (10) Completely hydrolyzed terpolymers of methyl acrylate, divinylbenzene, and acrylonitrile. (11) Sulfonated terpolymers of styrene, divinylbenzene, and acrylonitrile or methyl acrylate. (12) Methyl acrylate-divinylbenzene copolymer containing not less than 2 percent by weight of divinylbenzene, aminolyzed with dimethylaminopro-pylamine. (13) Methyl acrylate-divinylbenzene copolymer containing not less than 3.5 percent by weight of divinylbenzene, aminolyzed with dimethylami… | |||
| 21:21:3.0.1.1.4.1.1.6 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.40 Molecular sieve resins. | FDA | Molecular sieve resins may be safely used in the processing of food under the following prescribed conditions: (a) The molecular sieve resins consist of purified dextran having an average molecular weight of 40,000, cross-linked with epichlorohydrin in a ratio of 1 part of dextran to 10 parts of epichlorohydrin, to give a stable three dimensional structure. The resins have a pore size of 2.0 to 3.0 milliliters per gram of dry resin (expressed in terms of water regain), and a particle size of 10 to 300 microns. (b) The molecular sieve resins are thoroughly washed with potable water prior to their first use in contact with food. (c) Molecular sieve resins are used as the gel filtration media in the final purification of partially delactosed whey. The gel bed shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent microbial build-up on the bed and adulteration of the product. | ||||
| 21:21:3.0.1.1.4.1.1.7 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.45 Polymaleic acid and its sodium salt. | FDA | [51 FR 5315, Feb. 13, 1986, as amended at 61 FR 386, Jan. 5, 1996; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016; 88 FR 17722, Mar. 24, 2023] | Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS Reg. No. 70247-90-4) may be safely used in food in accordance with the following prescribed conditions: (a) The additives have a weight-average molecular weight in the range of 540 to 850 and a number-average molecular weight in the range of 520 to 650, calculated as the acid. Molecular weights shall be determined by a method entitled “Determination of Molecular Weight Distribution of Poly(Maleic) Acid,” March 17, 1992, produced by Ciba-Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or are available for inspection at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) The additives may be used, individually or together, in the processing of beet sugar juice and liquor or of cane sugar juice and liquor to control mineral scale. (c) The additives are to be used so that the amount of either or both additives does not exceed 4 parts per million (calculated as the acid) by weight of the beet or cane sugar juice or liquor process stream. | |||
| 21:21:3.0.1.1.4.1.1.8 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.50 Polyvinylpolypyrrolidone. | FDA | The food additive polyvinylpolypyrrolidone may be safely used in accordance with the following prescribed conditions: (a) The additive is a homopolymer of purified vinylpyrrolidone catalytically produced under conditions producing polymerization and cross-linking such that an insoluble polymer is produced. (b) The food additive is so processed that when the finished polymer is refluxed for 3 hours with water, 5 percent acetic acid, and 50 percent alcohol, no more than 50 parts per million of extractables is obtained with each solvent. (c) It is used or intended for use as a clarifying agent in beverages and vinegar, followed by removal with filtration. | ||||
| 21:21:3.0.1.1.4.1.1.9 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | A | Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment | § 173.55 Polyvinylpyrrolidone. | FDA | The food additive polyvinylpyrroli-done may be safely used in accordance with the following prescribed conditions: (a) The additive is a polymer of purified vinylpyrrolidone catalytically produced, having an average molecular weight of 40,000 and a maximum unsaturation of 1 percent, calculated as the monomer, except that the polyvinylpyrrolidone used in beer is that having an average molecular weight of 360,000 and a maximum unsaturation of 1 percent, calculated as the monomer. (b) The additive is used or intended for use in foods as follows: | ||||
| 21:21:3.0.1.1.4.2.1.1 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.110 Amyloglucosidase derived from | FDA | Amyloglucosidase enzyme product, consisting of enzyme derived from Rhizopus niveus, and diatomaceous silica as a carrier, may be safely used in food in accordance with the following conditions: (a) Rhizopus niveus is classified as follows: Class, Phycomycetes; order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, niveus. (b) The strain of Rhizopus niveus is nonpathogenic and nontoxic in man or other animals. (c) The enzyme is produced by a process which completely removes the organism Rhizopus niveus from the amyloglucosidase. (d) The additive is used or intended for use for degrading gelatinized starch into constituent sugars, in the production of distilled spirits and vinegar. (e) The additive is used at a level not to exceed 0.1 percent by weight of the gelatinized starch. | ||||
| 21:21:3.0.1.1.4.2.1.10 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.165 | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 78 FR 71466, Nov. 29, 2013; 88 FR 17722, Mar. 24, 2023] | The food additive Candida lipolytica may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions: (a) The food additive is the enzyme system of the organism Candida lipolytica and its concimitant metabolites produced during the fermentation process. (b)(1) The nonpathogenic organism is classified as follows: Class: Deuteromycetes. Order: Moniliales. Family: Cryptococcaceae. Genus: Candida. Species: lipolytica. Class: Deuteromycetes. Order: Moniliales. Family: Cryptococcaceae. Genus: Candida. Species: lipolytica. (2) The taxonomic characteristics of the culture agree in essential with the standard description for Candida lipolytica variety lipolytica listed in “The Yeasts—A Toxonomic Study,” 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) The additive is used or intended for use as a pure culture in the fermentation process for the production of citric acid from purified normal alkanes. (d) The additive is so used that the citric acid produced conforms to the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Fo… | |||
| 21:21:3.0.1.1.4.2.1.11 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.170 Aminoglycoside 3′-phosphotransferase II. | FDA | [59 FR 26711, May 23, 1994] | The food additive aminoglycoside 3′-phosphotransferase II may be safely used in the development of genetically modified cotton, oilseed rape, and tomatoes in accordance with the following prescribed conditions: (a) The food additive is the enzyme aminoglycoside 3′-phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the phosphorylation of certain aminoglycoside antibiotics, including kanamycin, neomycin, and gentamicin. (b) Aminoglycoside 3′-phosphotransferase II is encoded by the kan r gene originally isolated from transposon Tn 5 of the bacterium Escherichia coli. (c) The level of the additive does not exceed the amount reasonably required for selection of plant cells carrying the kan r gene along with the genetic material of interest. | |||
| 21:21:3.0.1.1.4.2.1.2 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.115 Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis. | FDA | [66 FR 27022, May 16, 2001, as amended at 88 FR 17722, Mar. 24, 2023] | The food additive alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation, may be safely used in accordance with the following conditions: (a) The food additive is the enzyme preparation derived from a modified Bacillus subtilis strain that contains the gene coding for α-ALDC from Bacillus brevis. (b)(1) The manufacturer produces the additive from a pure culture fermentation of a strain of Bacillus subtilis that is nonpathogenic and nontoxigenic in man or other animals. (2) The manufacturer may stabilize the enzyme preparation with glutaraldehyde or with other suitable approved food additives or generally recognized as safe substances. (3) The enzyme preparation must meet the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 4th ed., 1996, pp. 133-134, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) The additive is used in an amount not in excess of the minimum required to produce its intended effect as a processing aid in the production of alcoholic malt beverages and distilled liquors. | |||
| 21:21:3.0.1.1.4.2.1.3 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.120 Carbohydrase and cellulase derived from | FDA | Carbohydrase and cellulase enzyme preparation derived from Aspergillus niger may be safely used in food in accordance with the following prescribed conditions: (a) Aspergillus niger is classified as follows: Class, Deuteromycetes; order, Moniliales; family, Moniliaceae; genus, Aspergillus; species, niger. (b) The strain of Aspergillus niger is nonpathogenic and nontoxic in man or other animals. (c) The additive is produced by a process that completely removes the organism Aspergillus niger from the carbohydrase and cellulase enzyme product. (d) The additive is used or intended for use as follows: (1) For removal of visceral mass (bellies) in clam processing. (2) As an aid in the removal of the shell from the edible tissue in shrimp processing. (e) The additive is used in an amount not in excess of the minimum required to produce its intended effect. | ||||
| 21:21:3.0.1.1.4.2.1.4 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.130 Carbohydrase derived from | FDA | Carbohydrase from Rhizopus oryzae may be safely used in the production of dextrose from starch in accordance with the following prescribed conditions: (a) Rhizopus oryzae is classified as follows: Class, Phycomycetes; order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, Rhizopus oryzae. (b) The strain of Rhizopus oryzae is nonpathogenic and nontoxic. (c) The carbohydrase is produced under controlled conditions to maintain nonpathogenicity and nontoxicity, including the absence of aflatoxin. (d) The carbohydrase is produced by a process which completely removes the organism Rhizopus oryzae from the carbohydrase product. (e) The carbohydrase is maintained under refrigeration from production to use and is labeled to include the necessity of refrigerated storage. | ||||
| 21:21:3.0.1.1.4.2.1.5 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.135 Catalase derived from | FDA | Bacterial catalase derived from Micrococcus lysodeikticus by a pure culture fermentation process may be safely used in destroying and removing hydrogen peroxide used in the manufacture of cheese, in accordance with the following conditions. (a) The organism Micrococcus lysodeikticus from which the bacterial catalase is to be derived is demonstrated to be nontoxic and nonpathogenic. (b) The organism Micrococcus lysodeikticus is removed from the bacterial catalase prior to use of the bacterial catalase. (c) The bacterial catalase is used in an amount not in excess of the minimum required to produce its intended effect. | ||||
| 21:21:3.0.1.1.4.2.1.6 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.140 Esterase-lipase derived from | FDA | [47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, 1983] | Esterase-lipase enzyme, consisting of enzyme derived from Mucor miehei var. Cooney et Emerson by a pure culture fermentation process, with maltodextrin or sweet whey as a carrier, may be safely used in food in accordance with the following conditions: (a) Mucor miehei var. Cooney et Emerson is classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, Mucor; species, miehei; variety Cooney et Emerson. (b) The strain of Mucor miehei var. Cooney et Emerson is nonpathogenic and nontoxic in man or other animals. (c) The enzyme is produced by a process which completely removes the organism Mucor miehei var. Cooney et Emerson from the esterase-lipase. (d) The enzyme is used as a flavor enhancer as defined in § 170.3(o)(12). (e) The enzyme is used at levels not to exceed current good manufacturing practice in the following food categories: cheeses as defined in § 170.3(n)(5) of this chapter; fat and oils as defined in § 170.(3)(n)(12) of this chapter; and milk products as defined in § 170.(3)(n)(31) of this chapter. Use of this food ingredient is limited to nonstandarized foods and those foods for which the relevant standards of identity permit such use. (f) The enzyme is used in the minimum amount required to produce its limited technical effect. | |||
| 21:21:3.0.1.1.4.2.1.7 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.145 Alpha-Galactosidase derived from | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12, 1989] | The food additive alpha-galactosidase and parent mycelial microorganism Mortierella vinaceae var. raffinoseutilizer may be safely used in food in accordance with the following conditions: (a) The food additive is the enzyme alpha-galactosidase and the mycelia of the microorganism Mortierella vinaceae var. raffinoseutilizer which produces the enzyme. (b) The nonpathogenic microorganism matches American Type Culture Collection (ATCC) No. 20034, 1 and is classified as follows: 1 Available from: American Type Culture Collection, 12301 Parklawn Drive, Rockville, MD 20852. Class: Phycomycetes. Order: Mucorales. Family: Mortierellaceae. Genus: Mortierella. Species: vinaceae. Variety: raffinoseutilizer. Class: Phycomycetes. Order: Mucorales. Family: Mortierellaceae. Genus: Mortierella. Species: vinaceae. Variety: raffinoseutilizer. (c) The additive is used or intended for use in the production of sugar (sucrose) from sugar beets by addition as mycelial pellets to the molasses to increase the yield of sucrose, followed by removal of the spent mycelial pellets by filtration. (d) The enzyme removal is such that there are no enzyme or mycelial residues remaining in the finished sucrose. | |||
| 21:21:3.0.1.1.4.2.1.8 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.150 Milk-clotting enzymes, microbial. | FDA | [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 62 FR 59284, Nov. 3, 1997] | Milk-clotting enzyme produced by pure-culture fermentation process may be safely used in the production of cheese in accordance with the following prescribed conditions: (a) Milk-clotting enzyme is derived from one of the following organisms by a pure-culture fermentation process: (1) Endothia parasitica classified as follows: Class, Ascomycetes; order, Sphaeriales; family, Diaporthacesae; genus, Endothia; species, parasitica. (2) Bacillus cereus classified as follows: Class, Schizomycetes; order, Eubacteriales; family, Bacillaceae; genus, Bacillus; species, cereus (Frankland and Frankland). (3) Mucor pusillus Lindt classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, Mucor; species, pusillus; variety, Lindt. (4) Mucor miehei Cooney et Emerson classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, Mucor; species, miehei; variety, Cooney et Emerson. (5) Aspergillus oryzae modified by recombinant deoxyribonucleic (DNA) techniques to contain the gene coding for aspartic proteinase from Rhizomucor miehei var. Cooney et Emerson as defined in paragraph (a)(4) of this section, and classified as follows: Class, Blastodeuteromycetes (Hyphomycetes); order, Phialidales (Moniliales); genus, Aspergillus ; species oryzae. (b) The strains of organism identified in paragraph (a) of this section are nonpathogenic and nontoxic in man or other animals. (c) The additive is produced by a process that completely removes the generating organism from the milk-clotting enzyme product. (d) The additive is used in an amount not in excess of the minimum required to produce its intended effect in the production of those cheeses for which it is permitted by standards of identity established pursuant to section 401 of the Act. | |||
| 21:21:3.0.1.1.4.2.1.9 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Enzyme Preparations and Microorganisms | § 173.160 | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 78 FR 71466, Nov. 29, 2013; 88 FR 17722, Mar. 24, 2023] | The food additive Candida guilliermondii may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions: (a) The food additive is the enzyme system of the viable organism Candida guilliermondii and its concomitant metabolites produced during the fermentation process. (b)(1) The nonpathogenic and nontoxicogenic organism descending from strain, American Type Culture Collection (ATCC) No. 20474, 1 is classified as follows: 1 Available from: American Type Culture Collection, 12301 Parklawn Drive, Rockville, MD 20852. Class: Deuteromycetes. Order: Moniliales. Family: Cryptococcaceae. Genus: Candida. Species: guilliermondii. Variety: guilliermondii. Class: Deuteromycetes. Order: Moniliales. Family: Cryptococcaceae. Genus: Candida. Species: guilliermondii. Variety: guilliermondii. (2) The toxonomic characteristics of the reference culture strain ATCC No. 20474 agree in the essentials with the standard description for Candida guilliermondii variety guilliermondii listed in “The Yeasts—A Toxonomic Study;” 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c)(1) The additive is used or intended for use as a pure culture in the fermentation process for the production of citric acid using an acceptable aqueous carbohydrate substrate. (2) The organism Candida quilliermondii is made nonviable and is completely removed from the citric acid during the recovery and purification process. (d) The additive is so used that the citric acid … | |||
| 21:21:3.0.1.1.4.3.1.1 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.210 Acetone. | FDA | A tolerance of 30 parts per million is established for acetone in spice oleoresins when present therein as a residue from the extraction of spice. | ||||
| 21:21:3.0.1.1.4.3.1.10 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.280 Solvent extraction process for citric acid. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19, 1984; 78 FR 71466, Nov. 29, 2013; 88 FR 17722, Mar. 24, 2023] | A solvent extraction process for recovery of citric acid from conventional Aspergillus niger fermentation liquor may be safely used to produce food-grade citric acid in accordance with the following conditions: (a) The solvent used in the process consists of a mixture of n- octyl alcohol meeting the requirements of § 172.864 of this chapter, synthetic isoparaffinic petroleum hydrocarbons meeting the requirements of § 172.882 of this chapter, and tridodecyl amine. (b) The component substances are used solely as a solvent mixture and in a manner that does not result in formation of products not present in conventionally produced citric acid. (c) The citric acid so produced meets the polynuclear aromatic hydrocarbon specifications of § 173.165 and the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (d) Residues of n- octyl alcohol and synthetic isoparaffinic petroleum hydrocarbons are removed in accordance with good manufacturing practice. Current good manufacturing practice results in residues not exceeding 16 parts per million (ppm) n- octyl alcohol and 0.47 ppm synthetic isoparaffinic petroleum hydrocarbons in citric acid. (e) Tridodecyl amine may be present as a residue in citric acid at a level not to exceed 100 parts per bil… | |||
| 21:21:3.0.1.1.4.3.1.11 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.290 Trichloroethylene. | FDA | Tolerances are established for residues of trichloroethylene resulting from its use as a solvent in the manufacture of foods as follows: | ||||
| 21:21:3.0.1.1.4.3.1.2 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.220 1,3-Butylene glycol. | FDA | 1,3-Butylene glycol (1,3-butanediol) may be safely used in food in accordance with the following prescribed conditions: (a) The substance meets the following specifications: (1) 1,3-Butylene glycol content: Not less than 99 percent. (2) Specific gravity at 20/20 °C: 1.004 to 1.006. (3) Distillation range: 200°-215 °C. (b) It is used in the minimum amount required to perform its intended effect. (c) It is used as a solvent for natural and synthetic flavoring substances except where standards of identity issued under section 401 of the act preclude such use. | ||||
| 21:21:3.0.1.1.4.3.1.3 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.228 Ethyl acetate. | FDA | [47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984; 78 FR 71466, Nov. 29, 2013; 88 FR 17722, Mar. 24, 2023] | Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in accordance with the following conditions: (a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 343-344, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (b) The additive is used in accordance with current good manufacturing practice as a solvent in the decaffeination of coffee and tea. | |||
| 21:21:3.0.1.1.4.3.1.4 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.230 Ethylene dichloride. | FDA | A tolerance of 30 parts per million is established for ethylene dichloride in spice oleoresins when present therein as a residue from the extraction of spice; Provided, however, That if residues of other chlorinated solvents are also present the total of all residues of such solvents shall not exceed 30 parts per million. | ||||
| 21:21:3.0.1.1.4.3.1.5 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.240 Isopropyl alcohol. | FDA | Isopropyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million. (b) In lemon oil as a residue in production of the oil, at a level not to exceed 6 parts per million. (c) In hops extract as a residue from the extraction of hops at a level not to exceed 2.0 percent by weight: Provided, That, (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the isopropyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (c)(1) of this section. | ||||
| 21:21:3.0.1.1.4.3.1.6 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.250 Methyl alcohol residues. | FDA | Methyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million. (b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of methyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section. | ||||
| 21:21:3.0.1.1.4.3.1.7 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.255 Methylene chloride. | FDA | Methylene chloride may be present in food under the following conditions: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 30 parts per million; Provided, That, if residues of other chlorinated solvents are also present, the total of all residues of such solvents shall not exceed 30 parts per million. (b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent, Provided, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract identifies the presence of the methylene chloride and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section. (c) In coffee as a residue from its use as a solvent in the extraction of caffeine from green coffee beans, at a level not to exceed 10 parts per million (0.001 percent) in decaffeinated roasted coffee and in decaffeinated soluble coffee extract (instant coffee). | ||||
| 21:21:3.0.1.1.4.3.1.8 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.270 Hexane. | FDA | Hexane may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 25 parts per million. (b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the hexane and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section. | ||||
| 21:21:3.0.1.1.4.3.1.9 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Solvents, Lubricants, Release Agents and Related Substances | § 173.275 Hydrogenated sperm oil. | FDA | The food additive hydrogenated sperm oil may be safely used in accordance with the following prescribed conditions: (a) The sperm oil is derived from rendering the fatty tissue of the sperm whale or is prepared by synthesis of fatty acids and fatty alcohols derived from the sperm whale. The sperm oil obtained by rendering is refined. The oil is hydrogenated. (b) It is used alone or as a component of a release agent or lubricant in bakery pans. (c) The amount used does not exceed that reasonably required to accomplish the intended lubricating effect. | ||||
| 21:21:3.0.1.1.4.4.1.1 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.300 Chlorine dioxide. | FDA | [60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, as amended at 61 FR 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; 65 FR 34587, May 31, 2000; 70 FR 7396, Feb. 14, 2005; 81 FR 5592, Feb. 3, 2016; 88 FR 17723, Mar. 24, 2023] | Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in food in accordance with the following prescribed conditions: (a)(1) The additive is generated by one of the following methods: (i) Treating an aqueous solution of sodium chlorite with either chlorine gas or a mixture of sodium hypochlorite and hydrochloric acid. (ii) Treating an aqueous solution of sodium chlorate with hydrogen peroxide in the presence of sulfuric acid. (iii) Treating an aqueous solution of sodium chlorite by electrolysis. (2) The generator effluent contains at least 90 percent (by weight) of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO 2 E in the “Standard Methods for the Examination of Water and Wastewater,” 20th ed., 1998, or an equivalent method. Method 4500-ClO 2 E (“Amperometric Method II”) is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or the American Public Health Association, 800 I St. NW., Washington, DC 20001-3750. You may inspect a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b)(1) The additive may be used as an antimicrobial agent in water used in poultry processing in an amount not to exceed 3 parts per million (ppm) residual chlorine dioxide as determined by Method 4500-ClO 2 E, referenced in paragraph (a)(2) of this section, or an equivalent method. (2) The additive may be used as an antimicrobial agent in water used to wash fruits and vegetables… | |||
| 21:21:3.0.1.1.4.4.1.10 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.350 Combustion product gas. | FDA | The food additive combustion product gas may be safely used in the processing and packaging of the foods designated in paragraph (c) of this section for the purpose of removing and displacing oxygen in accordance with the following prescribed conditions: (a) The food additive is manufactured by the controlled combustion in air of butane, propane, or natural gas. The combustion equipment shall be provided with an absorption-type filter capable of removing possible toxic impurities, through which all gas used in the treatment of food shall pass; and with suitable controls to insure that any combustion products failing to meet the specifications provided in this section will be prevented from reaching the food being treated. (b) The food additive meets the following specifications: (1) Carbon monoxide content not to exceed 4.5 percent by volume. (2) The ultraviolet absorbance in isooctane solution in the range 255 millimicrons to 310 millimicrons not to exceed one-third of the standard reference absorbance when tested as described in paragraph (e) of this section. (c) It is used or intended for use to displace or remove oxygen in the processing, storage, or packaging of beverage products and other food, except fresh meats. (d) To assure safe use of the additive in addition to the other information required by the act, the label or labeling of the combustion device shall bear adequate directions for use to provide a combustion product gas that complies with the limitations prescribed in paragraph (b) of this section, including instructions to assure proper filtration. (e) The food additive is tested for compliance with paragraph (b)(2) by the following empirical method: Spectrophotometric measurements. All measurements are made in an ultraviolet spectrophotometer in optical cells of 5 centimeters in length, and in the range of 255 millimicrons to 310 millimicrons, under the same instrumental conditions. The standard reference absorbance is the absorbance at 275 millimicrons of a standard reference solution o… | ||||
| 21:21:3.0.1.1.4.4.1.11 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.355 Dichlorodifluoromethane. | FDA | The food additive dichlorodifluoromethane may be safely used in food in accordance with the following prescribed conditions: (a) The additive has a purity of not less than 99.97 percent. (b) It is used or intended for use, in accordance with good manufacturing practice, as a direct-contact freezing agent for foods. (c) To assure safe use of the additive: (1) The label of its container shall bear, in addition to the other information required by the act, the following: (i) The name of the additive, dichlorodifluoromethane, with or without the parenthetical name “Food Freezant 12”. (ii) The designation “food grade”. (2) The label or labeling of the food additive container shall bear adequate directions for use. | ||||
| 21:21:3.0.1.1.4.4.1.12 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.356 Hydrogen peroxide. | FDA | [90 FR 42537, Sept. 3, 2025] | Hydrogen peroxide (H 2 O 2 , CAS Reg. No. 7722-84-1) may be safely used to treat food in accordance with the following conditions: (a) Hydrogen peroxide meets the specifications of Hydrogen Peroxide, Food Chemicals Codex, 14th edition, effective June 1, 2024, which is incorporated by reference into this section. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA at: the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday; phone: 240-402-7500; email: IBR_Material_Inquiries@fda.hhs.gov. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov. The material may be obtained from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852; phone: 800-822-8772; email: fcc@usp.org; website: https://www.usp.org. (b) The additive is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter, oxidizing and reducing agent defined in § 170.3(o)(22) of this chapter, and bleaching agent, and to remove sulfur dioxide in accordance with good manufacturing practice. (c) Residual hydrogen peroxide is removed by appropriate chemical or physical means during the processing of food where it has been used. | |||
| 21:21:3.0.1.1.4.4.1.13 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.357 Materials used as fixing agents in the immobilization of enzyme preparations. | FDA | [48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, 1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, June 25, 2002; 81 FR 5592, Feb. 3, 2016; 88 FR 17723, Mar. 24, 2023] | Fixing agents may be safely used in the immobilization of enzyme preparations in accordance with the following conditions: (a) The materials consist of one or more of the following: (1) Substances generally recognized as safe in food. (2) Substances identified in this subparagraph and subject to such limitations as are provided: (b) The fixed enzyme preparation is washed to remove residues of the fixing materials. | |||
| 21:21:3.0.1.1.4.4.1.14 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.360 Octafluorocyclobutane. | FDA | The food additive octafluorocyclo-butane may be safely used as a propellant and aerating agent in foamed or sprayed food products in accordance with the following conditions: (a) The food additive meets the following specifications: 99.99 percent octafluorocyclobutane. Less than 0.1 part per million fluoroolefins, calculated as perfluoroisobutylene. 99.99 percent octafluorocyclobutane. Less than 0.1 part per million fluoroolefins, calculated as perfluoroisobutylene. (b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, and propane, as a propellant and aerating agent for foamed or sprayed food products, except for those standardized foods that do not provide for such use. (c) To assure safe use of the additive: (1) The label of the food additive container shall bear, in addition to the other information required by the act, the following: (i) The name of the additive, octafluorocyclobutane. (ii) The percentage of the additive present in the case of a mixture. (iii) The designation “food grade”. (2) The label or labeling of the food additive container shall bear adequate directions for use. | ||||
| 21:21:3.0.1.1.4.4.1.15 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.368 Ozone. | FDA | [66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002, as amended at 78 FR 14665, Mar. 7, 2013; 78 FR 71467, Nov. 29, 2013; 88 FR 17724, Mar. 24, 2023] | Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319), in accordance with the following prescribed conditions: (a) The additive is an unstable, colorless gas with a pungent, characteristic odor, which occurs freely in nature. It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen. (b) The additive is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter. (c) The additive meets the specifications for ozone in the Food Chemicals Codex, 7th ed. (2010), pp. 754-755, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (d) The additive is used in contact with food, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase in accordance with current industry standards of good manufacturing practice. (e) When used on raw agricultural commodities, the use is consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act. | |||
| 21:21:3.0.1.1.4.4.1.16 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.370 Peroxyacids. | FDA | [65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, 2002; 81 FR 5593, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | Peroxyacids may be safely used in accordance with the following prescribed conditions: (a) The additive is a mixture of peroxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-1,1-diphosphonic acid. (b)(1) The additive is used as an antimicrobial agent on meat carcasses, parts, trim, and organs in accordance with current industry practice where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, and the maximum concentration of hydrogen peroxide is 75 ppm. (2) The additive is used as an antimicrobial agent on poultry carcasses, poultry parts, and organs in accordance with current industry standards of good manufacturing practice (unless precluded by the U.S. Department of Agriculture's standards of identity in 9 CFR part 381, subpart P) where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, the maximum concentration of hydrogen peroxide is 110 ppm, and the maximum concentration of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) is 13 ppm. (c) The concentrations of peroxyacids and hydrogen peroxide in the additive are determined by a method entitled “Hydrogen Peroxide and Peracid (as Peracetic Acid) Content,” July 26, 2000, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The concentration of 1-hydroxyethylidene-1,1-diphosphonic acid is determined by a method entitled “Determination of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) Peroxyacid/Peroxide-Containing Solutions,” August 21, 2001, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The Director of the Office of the Federal Register approves these incorporations by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or you may e… | |||
| 21:21:3.0.1.1.4.4.1.17 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.375 Cetylpyridinium chloride. | FDA | [72 FR 67576, Nov. 29, 2007, as amended at 76 FR 59248, Sept. 26, 2011; 81 FR 5593, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used in food in accordance with the following conditions: (a) The additive meets the specifications of the United States Pharmacopeia (USP)/National Formulary (NF) described in USP 30/NF 25, May 1, 2007, pp. 1700-1701, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or you may examine a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (b) The additive is used in food as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter to treat the surface of raw poultry carcasses. The solution in which the additive is used to treat raw poultry carcasses shall also contain propylene glycol (CAS Reg. No. 57-55-6) complying with § 184.1666 of this chapter, at a concentration of 1.5 times that of cetylpyridinium chloride. (c) The additive is used as follows: (1) As a fine mist spray of an ambient temperature aqueous solution applied to raw poultry carcasses prior to immersion in a chiller, at a level not to exceed 0.3 gram cetylpyridinium chloride per pound of raw poultry carcass, provided that the additive is used in systems that collect and recycle solution that is not carried out of the system with the treated poultry carcasses; or (2) As a liquid aqueous solution applied to raw poultry carcasses either prior to or after chilling at an amount not to exceed 5 gallons of solution per carcass, provided that the additive is used in systems that… | |||
| 21:21:3.0.1.1.4.4.1.18 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.385 Sodium methyl sulfate. | FDA | Sodium methyl sulfate may be present in pectin in accordance with the following conditions. (a) It is present as the result of methylation of pectin by sulfuric acid and methyl alcohol and subsequent treatment with sodium bicarbonate. (b) It does not exceed 0.1 percent by weight of the pectin. | ||||
| 21:21:3.0.1.1.4.4.1.19 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.395 Trifluoromethane sulfonic acid. | FDA | [43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] | Trifluoromethane sulfonic acid has the empirical formula CF 3 SO 3 H (CAS Reg. No. 1493-13-6). The catalyst (Trifluoromethane sulfonic acid) may safely be used in the production of cocoa butter substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin) (see § 184.1259 of this chapter) in accordance with the following conditions: (a) The catalyst meets the following specifications: Appearance, Clear liquid. Color, Colorless to amber. Neutralization equivalent, 147-151. Water, 1 percent maximum. Fluoride ion, 0.03 percent maximum. Heavy metals (as Pb), 30 parts per million maximum. Arsenic (as As), 3 parts per million maximum. Appearance, Clear liquid. Color, Colorless to amber. Neutralization equivalent, 147-151. Water, 1 percent maximum. Fluoride ion, 0.03 percent maximum. Heavy metals (as Pb), 30 parts per million maximum. Arsenic (as As), 3 parts per million maximum. (b) It is used at levels not to exceed 0.2 percent of the reaction mixture to catalyze the directed esterification. (c) The esterification reaction is quenched with steam and water and the catalyst is removed with the aqueous phase. Final traces of catalyst are removed by washing batches of the product three times with an aqueous solution of 0.5 percent sodium bicarbonate. (d) No residual catalyst may remain in the product at a detection limit of 0.2 part per million fluoride as determined by the method described in “Official Methods of Analysis of the Association of Official Analytical Chemists,” sections 25.049-25.055, 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. | |||
| 21:21:3.0.1.1.4.4.1.2 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.310 Boiler water additives. | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227, June 1, 1999; 78 FR 71466, Nov. 29, 2013; 88 FR 17723, Mar. 24, 2023] | Boiler water additives may be safely used in the preparation of steam that will contact food, under the following conditions: (a) The amount of additive is not in excess of that required for its functional purpose, and the amount of steam in contact with food does not exceed that required to produce the intended effect in or on the food. (b) The compounds are prepared from substances identified in paragraphs (c) and (d) of this section, and are subject to the limitations, if any, prescribed: (c) List of substances: (d) Substances used alone or in combination with substances in paragraph (c) of this section: (e) To assure safe use of the additive, in addition to the other information required by the Act, the label or labeling shall bear: (1) The common or chemical name or names of the additive or additives. (2) Adequate directions for use to assure compliance with all the provisions of this section. (f) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (1) Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday: (i) “Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS” (October 23, 1987). (ii) [Reserved] (2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ): (i) Food Chemicals Codex, 7th ed. (2010), pp. 1128-1129. (ii) Fo… | |||
| 21:21:3.0.1.1.4.4.1.20 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.400 Dimethyldialkylammonium chloride. | FDA | [56 FR 42686, Aug. 29, 1991, as amended at 88 FR 17724, Mar. 24, 2023] | Dimethyldialkylammonium chloride may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is produced by one of the following methods: (1) Ammonolysis of natural tallow fatty acids to form amines that are subsequently reacted with methyl chloride to form the quaternary ammonium compounds consisting primarily of dimethyldioctadecylammonium chloride and dimethyldihexadecylammonium chloride. The additive may contain residues of isopropyl alcohol not in excess of 18 percent by weight when used as a processing solvent. (2) Ammonolysis of natural tallow fatty acids to form amines that are then reacted with 2-ethylhexanal, reduced, methylated, and subsequently reacted with methyl chloride to form the quaternary ammonium compound known as dimethyl(2-ethylhexyl) hydrogenated tallow ammonium chloride and consisting primarily of dimethyl(2-ethylhexyl)octadecylammonium chloride and dimethyl(2-ethylhexyl)hexadecylammonium chloride. (b) The food additive described in paragraph (a)(1) of this section contains not more than a total of 2 percent by weight of free amine and amine hydrochloride. The food additive described in paragraph (a)(2) of this section contains not more than 3 percent by weight, each, of free amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64, “Acid Value and Free Amine Value of Fatty Quaternary Ammonium Chlorides,” 2d printing including additions and revisions 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, and from the American Oil Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archiv… | |||
| 21:21:3.0.1.1.4.4.1.21 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.405 Sodium dodecylbenzenesulfonate. | FDA | [77 FR 71697, Dec. 4, 2012] | Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) may be safely used in accordance with the following prescribed conditions: (a) The additive is an antimicrobial agent used in wash water for fruits and vegetables. The additive may be used at a level not to exceed 111 milligrams per kilogram in the wash water. Fruits and vegetables treated by the additive do not require a potable water rinse. (b) The additive is limited to use in commissaries, cafeterias, restaurants, retail food establishments, nonprofit food establishments, and other food service operations in which food is prepared for or served directly to the consumer. (c) To assure safe use of the additive, the label or labeling of the additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with the provisions of this section. | |||
| 21:21:3.0.1.1.4.4.1.3 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.315 Chemicals used in washing or to assist in the peeling of fruits and vegetables. | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 42 FR 29856, June 10, 1977; 42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19, 1999] | Chemicals may be safely used to wash or to assist in the peeling of fruits and vegetables in accordance with the following conditions: (a) The chemicals consist of one or more of the following: (1) Substances generally recognized as safe in food or covered by prior sanctions for use in washing fruits and vegetables. (2) Substances identified in this subparagraph and subject to such limitations as are provided: (3) Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-260) may be used in the steam/scald vacuum peeling of tomatoes at a level not to exceed 0.2 percent in the condensate or scald water. (4) Substances identified in this paragraph (a)(4) for use in flume water for washing sugar beets prior to the slicing operation and subject to the limitations as are provided for the level of the substances in the flume water: (5) Substances identified in this paragraph (a)(5) for use on fruits and vegetables that are not raw agricultural commodities and subject to the limitations provided: (b) The chemicals are used in amounts not in excess of the minimum required to accomplish their intended effect. (c) The use of the chemicals listed under paragraphs (a)(1), (a)(2), and (a)(4) is followed by rinsing with potable water to remove, to the extent possible, residues of the chemicals. (d) To assure safe use of the additive: (1) The label and labeling of the additive container shall bear, in addition to the other information required by the act, the name of the additive or a statement of its composition. (2) The label or labeling of the additive container shall bear adequate use directions to assure use in compliance with all provisions of this section. | |||
| 21:21:3.0.1.1.4.4.1.4 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.320 Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills. | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 47 FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, 1985; 57 FR 8065, Mar. 6, 1992] | Agents for controlling microorganisms in cane-sugar and beet-sugar mills may be safely used in accordance with the following conditions: (a) They are used in the control of microorganisms in cane-sugar and/or beet-sugar mills as specified in paragraph (b) of this section. (b) They are applied to the sugar mill grinding, crusher, and/or diffuser systems in one of the combinations listed in paragraph (b)(1), (2), (3), or (5) of this section or as a single agent listed in paragraph (b)(4) or (6) of this section. Quantities of the individual additives in parts per million are expressed in terms of the weight of the raw cane or raw beets. (1) Combination for cane-sugar mills: (2) Combination for cane-sugar mills: (3) Combinations for cane-sugar mills and beet-sugar mills: (4) Single additive for cane-sugar mills and beet-sugar mills. (5) Combination for cane-sugar mills: Limitations. Byproduct molasses, bagasse, and pulp containing residues of these quaternary ammonium salts are not authorized for use in animal feed. (6) Single additive for beet-sugar mills: (c) To assure safe use of the additives, their label and labeling shall conform to that registered with the Environmental Protection Agency. | |||
| 21:21:3.0.1.1.4.4.1.5 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.322 Chemicals used in delinting cottonseed. | FDA | [47 FR 8346, Feb. 26, 1982] | Chemicals may be safely used to assist in the delinting of cottonseed in accordance with the following conditions: (a) The chemicals consist of one or more of the following: (1) Substances generally recognized as safe for direct addition to food. (2) Substances identified in this paragraph and subject to such limitations as are provided: | |||
| 21:21:3.0.1.1.4.4.1.6 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.325 Acidified sodium chlorite solutions. | FDA | [61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR 22922, May 7, 2001; 66 FR 31841, June 13, 2001; 67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30, 2004; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016; 88 FR 17723, Mar. 24, 2023] | Acidified sodium chlorite solutions may be safely used in accordance with the following prescribed conditions: (a) The additive is produced by mixing an aqueous solution of sodium chlorite (CAS Reg. No. 7758-19-2) with any generally recognized as safe (GRAS) acid. (b)(1) The additive is used as an antimicrobial agent in poultry processing water in accordance with current industry practice under the following conditions: (i) As a component of a carcass spray or dip solution prior to immersion of the intact carcass in a prechiller or chiller tank; (ii) In a prechiller or chiller solution for application to the intact carcass; (iii) As a component of a spray or dip solution for application to poultry carcass parts; (iv) In a prechiller or chiller solution for application to poultry carcass parts; or (v) As a component of a post-chill carcass spray or dip solution when applied to poultry meat, organs, or related parts or trim. (2) When used in a spray or dip solution, the additive is used at levels that result in sodium chlorite concentrations between 500 and 1,200 parts per million (ppm), in combination with any GRAS acid at a level sufficient to achieve a solution pH of 2.3 to 2.9. (3) When used in a prechiller or chiller solution, the additive is used at levels that result in sodium chlorite concentrations between 50 and 150 ppm, in combination with any GRAS acid at levels sufficient to achieve a solution pH of 2.8 to 3.2. (c) The additive is used as an antimicrobial agent in accordance with current industry practice in the processing of red meat, red meat parts, and organs as a component of a spray or in the processing of red meat parts and organs as a component of a dip. Applied as a dip or spray, the additive is used at levels that result in sodium chlorite concentrations between 500 and 1,200 ppm in combination with any GRAS acid at levels sufficient to achieve a solution pH of 2.5 to 2.9. (d)(1) The additive is used as an antimicrobial agent in water and ice that are used to rinse, wash, thaw, tran… | |||
| 21:21:3.0.1.1.4.4.1.7 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.340 Defoaming agents. | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR 29134, May 28, 1998; 81 FR 5592, Feb. 3, 2016; 88 FR 17723, Mar. 24, 2023] | Defoaming agents may be safely used in processing foods, in accordance with the following conditions: (a) They consist of one or more of the following: (1) Substances generally recognized by qualified experts as safe in food or covered by prior sanctions for the use prescribed by this section. (2) Substances listed in this paragraph (a)(2) of this section, subject to any limitations imposed: (3) Substances listed in this paragraph (a)(3), provided they are components of defoaming agents limited to use in processing beet sugar and yeast, and subject to any limitations imposed: (4) The substances listed in this paragraph (a)(4), provided they are components of defoaming agents limited to use in processing beet sugar only, and subject to the limitations imposed: (b) They are added in an amount not in excess of that reasonably required to inhibit foaming. | |||
| 21:21:3.0.1.1.4.4.1.8 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.342 Chlorofluorocarbon 113 and perfluorohexane. | FDA | [55 FR 8913, Mar. 9, 1990] | A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro-1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also known as fluorocarbon 113, CFC 113 and FC 113) and 1 percent perfluorohexane (CAS Reg. No. 355-42-0) may be safely used in accordance with the following prescribed conditions: (a) The additive chlorofluorocarbon 113 has a purity of not less than 99.99 percent. (b) The additive mixture is intended for use to quickly cool or crust-freeze chickens sealed in intact bags composed of substances regulated in parts 174, 175, 177, 178, and § 179.45 of this chapter and conforming to any limitations or specifications in such regulations. | |||
| 21:21:3.0.1.1.4.4.1.9 | 21 | Food and Drugs | I | B | 173 | PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Specific Usage Additives | § 173.345 Chloropentafluoroethane. | FDA | [42 FR 14526, Mar. 15, 1977, as amended at 43 FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, 1978] | The food additive chloropentafluoroethane may be safely used in food in accordance with the following prescribed conditions: (a) The food additive has a purity of not less than 99.97 percent, and contains not more than 200 parts per million saturated fluoro compounds and 10 parts per million unsaturated fluoro compounds as impurities. (b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, propane, and octafluorocyclobutane complying with § 173.360, as an aerating agent for foamed or sprayed food products, with any propellant effect being incidental and no more than is minimally necessary to achieve the aerating function, except that use is not permitted for those standardized foods that do not provide for such use. (c) To assure safe use of the additive (1) The label of the food additive container shall bear, in addition to the other information required by the act, the following: (i) The name of the additive, chloropentafluoroethane. (ii) The percentage of the additive present in the case of a mixture. (iii) The designation “food grade”. (2) The label or labeling of the food additive container shall bear adequate directions for use. | |||
| 33:33:2.0.1.8.37.1.228.1 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | A | Subpart A—General | § 173.1 Purpose; preemptive effect. | USCG | [USCG-2003-14963, 77 FR 18699, Mar. 28, 2012] | This part prescribes requirements for numbering vessels and for reporting casualties and accidents to implement sections 6101, 6102, 12301, and 12302 of Title 46, United States Code. The regulations in subparts A, B, and D of this part have preemptive effect over conflicting State or local regulation. The regulations in subpart C of this part have preemptive effect over State or local regulation within the same field, except to the extent that Congress requires the Coast Guard to allow State casualty reporting systems pursuant to 46 U.S.C. chapter 131. | |||
| 33:33:2.0.1.8.37.1.228.2 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | A | Subpart A—General | § 173.3 Definitions. | USCG | [USCG-2003-14963, 77 FR 18699, Mar. 28, 2012] | As used in this part— Airboat means a vessel that is typically flat-bottomed and propelled by an aircraft-type propeller powered by an engine. Auxiliary sail means a vessel with sail as its primary method of propulsion and mechanical propulsion as its secondary method. Cabin motorboat means a vessel propelled by propulsion machinery and providing enclosed spaces inside its structure. Certificate of number means the certificate required by § 173.21 of this part. Houseboat means a motorized vessel that is usually non-planing and designed primarily for multi-purpose accommodation spaces with low freeboard and little or no foredeck or cockpit. Hull identification number or HIN means a number required by 33 CFR 181.23. Inboard, in the context of an engine, means an engine mounted inside the confines of a vessel which powers a drive shaft that turns a water jet impeller or that runs through the bottom of the hull and is attached to a propeller at the other end. Inflatable boat means a vessel that uses air-filled flexible fabric for buoyancy. Issuing authority means a State listed in appendix A of this part as having a numbering system approved by the Coast Guard or the Coast Guard itself when a State numbering system has not been approved. Open motorboat means a vessel equipped with propulsion machinery and having an open load carrying area that does not have a continuous deck to protect it from the entry of water. Operate means use, navigate, or employ. Operator means the person who is in control or in charge of a vessel while it is in operation. Outboard, in the context of an engine, means an engine with propeller or water jet integrally attached, which is usually mounted at the stern of a vessel. Owner means a person, other than a secured party, having property rights in or title to a vessel, including persons entitled to use or possess a vessel subject to a security interest in another person, but excluding lessees under a lease not intended as security. Paddlecraft means a vessel po… | |||
| 33:33:2.0.1.8.37.2.228.1 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.11 Applicability. | USCG | This subpart applies to each vessel equipped with propulsion machinery of any type used on waters subject to the jurisdiction of the United States and on the high seas beyond the territorial seas for vessels owned in the United States except: (a) Foreign vessels temporarily using waters subject to U.S. jurisdiction; (b) Military or public vessels of the United States, except recreational-type public vessels; (c) A vessel whose owner is a State or subdivision thereof, which is used principally for governmental purposes, and which is clearly identifiable as such; (d) Ships' lifeboats; (e) A vessel which has or is required to have a valid marine document as a vessel of the United States. | ||||
| 33:33:2.0.1.8.37.2.228.10 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.29 Notification to issuing authority. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-15404, 68 FR 37742, June 25, 2003] | A person whose name appears as the owner of a vessel on a certificate of number shall, within 15 days, notify the issuing authority in a manner prescribed by the issuing authority of: (a) Any change in his or her address; (b) The theft or recovery of the vessel; (c) The loss or destruction of a valid certificate of number; (d) The transfer of all or part of his or her interest in the vessel; and (e) The destruction or abandonment of the vessel. | |||
| 33:33:2.0.1.8.37.2.228.11 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.31 Surrender of certificate of number. | USCG | A person whose name appears as the owner of a vessel on a certificate of number shall surrender the certificate in a manner prescribed by the issuing authority within 15 days after it becomes invalid under paragraph (b), (c), (d), or (e) of § 173.77. | ||||
| 33:33:2.0.1.8.37.2.228.12 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.33 Removal of number. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-14963, 77 FR 18700, Mar. 28, 2012] | The person whose name appears on a certificate of number as the owner of a vessel shall remove the number and validation sticker from the vessel when: (a) The vessel is documented by the Coast Guard; (b) The certificate of number is invalid under paragraph (c) of § 173.77; or (c) The vessel is no longer principally operated in the State where the certificate was issued. | |||
| 33:33:2.0.1.8.37.2.228.13 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.35 Coast Guard validation sticker. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-14963, 77 FR 18700, Mar. 28, 2012] | No person may operate a vessel except a vessel exempted in § 173.13 that has a number issued by the Coast Guard unless it has the validation sticker issued with the certificate of number displayed within 6 inches of the number. | |||
| 33:33:2.0.1.8.37.2.228.2 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.13 Exemptions. | USCG | Where the Coast Guard issues numbers, the following classes of vessels are exempt, under Section 12303 of Title 46, United States Code, from the numbering provisions of Sections 12301 and 12302 of Title 46, United States Code, and this part: (a) A vessel that is used exclusively for racing. (b) A vessel equipped with propulsion machinery of less than 10 horsepower that: (1) Is owned by the owner of a vessel for which a valid certificate of number has been issued; (2) Displays the number of that numbered vessel followed by the suffix “1” in the manner prescribed in § 173.27; and (3) Is used as a tender for direct transportation between that vessel and the shore and for no other purpose. | ||||
| 33:33:2.0.1.8.37.2.228.3 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.15 Vessel number required. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-14963, 77 FR 18699, Mar. 28, 2012] | (a) Except as provided in § 173.17, no person may use a vessel to which this part applies unless: (1) It has a number issued on a certificate of number by the issuing authority in the State of principal operation; and (2) The number is displayed as described in § 173.27. (b) This section does not apply to a vessel for which a valid temporary certificate has been issued to its owner by the issuing authority in the State of principal operation. | |||
| 33:33:2.0.1.8.37.2.228.4 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.17 Reciprocity. | USCG | [CGD 89-048, 54 FR 27002, June 27, 1989] | (a) Section 12302(c) of Title 46, United States Code, states: When a vessel is numbered in a State, it is deemed in compliance with the numbering system of a State in which it temporarily is operated. When a vessel is numbered in a State, it is deemed in compliance with the numbering system of a State in which it temporarily is operated. (b) Section 12302(d) of Title 46, United States Code, states: When a vessel is removed to a new State of principal operation, the issuing authority of that State shall recognize the validity of the number issued by the original State for 60 days. When a vessel is removed to a new State of principal operation, the issuing authority of that State shall recognize the validity of the number issued by the original State for 60 days. | |||
| 33:33:2.0.1.8.37.2.228.5 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.19 Other numbers prohibited. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-14963, 77 FR 18699, Mar. 28, 2012] | No person may operate a vessel to which this part applies that has any number that is not issued by an issuing authority for that vessel on its forward half. | |||
| 33:33:2.0.1.8.37.2.228.6 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.21 Certificate of number required. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by CGD 77-117A, 43 FR 17941, Apr. 27, 1978; CGD 89-048, 54 FR 27002, June 27, 1989; USCG-2003-15404, 68 FR 37742, June 25, 2003; USCG-2003-14963, 77 FR 18699, Mar. 28, 2012; 89 FR 47983, July 5, 2024] | (a) Except as provided in §§ 173.13 and 173.17, no person may operate a vessel to which this part applies unless they have on board in hard copy or digital form: (1) A valid certificate of number or temporary certificate for that vessel issued by the issuing authority in the State in which the vessel is principally operated; or (2) For the vessel described in paragraph (b) of this section, a copy of the lease or rental agreement, signed by the owner or his or her authorized representative and by the person leasing or renting the vessel, that contains at least: (i) The vessel number that appears on the certificate of number; and (ii) The period of time for which the vessel is leased or rented. (b) Section 12304(a) of Title 46, United States Code, states in part: The certificate of number for a vessel less than 26 feet in length and leased or rented to another for the latter's noncommercial operation of less than 7 days may be retained on shore by the vessel's owner or representative at the place from which the vessel departs or returns to the possession of the owner or the owner's representative. | |||
| 33:33:2.0.1.8.37.2.228.7 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.23 Inspection of certificate. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-15404, 68 FR 37742, June 25, 2003; USCG-2003-14963, 77 FR 18700, Mar. 28, 2012] | Each person operating a vessel to which this part applies shall present the certificate or lease or rental agreement required by § 173.21 to any Federal, State, or local law enforcement officer for inspection at his or her request. | |||
| 33:33:2.0.1.8.37.2.228.8 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.25 Location of certificate of number. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-14963, 77 FR 18700, Mar. 28, 2012] | No person may operate a vessel to which this part applies unless the certificate or lease or rental agreement required by § 173.21 is carried on board in such a manner that it can be handed to a person authorized under § 173.23 to inspect it. | |||
| 33:33:2.0.1.8.37.2.228.9 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | B | Subpart B—Numbering | § 173.27 Numbers: Display; size; color. | USCG | (a) Each number required by § 173.15 must: (1) Be painted on or permanently attached to each side of the forward half of the vessel except as allowed by paragraph (b) or required by paragraph (c) of this section; (2) Be in plain vertical block characters of not less than 3 inches in height; (3) Contrast with the color of the background and be distinctly visible and legible; (4) Have spaces or hyphens that are equal to the width of a letter other than “I” or a number other than “1” between the letter and number groupings (Example: DC 5678 EF or DC-5678-EF); and (5) Read from left to right. (b) When a vessel is used by a manufacturer or by a dealer for testing or demonstrating, the number may be painted on or attached to removable plates that are temporarily but firmly attached to each side of the forward half of the vessel. (c) On vessels so configured that a number on the hull or superstructure would not be easily visible, the number must be painted on or attached to a backing plate that is attached to the forward half of the vessel so that the number is visible from each side of the vessel. (d) Each number displayed on a tender exempted under § 173.13 must meet the requirements of paragraph (a) of this section and have a space or hyphen that is equal to the width of a letter other than “I” or a number other than “1” between the suffix and the number. (Example: DC 5678 EF 1 or DC-5678-EF-1.) | ||||
| 33:33:2.0.1.8.37.3.228.1 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | C | Subpart C—Casualty and Accident Reporting | § 173.51 Applicability. | USCG | [CDG 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by CDG 84-099, 52 FR 47533, Dec. 14, 1987; USCG-2003-14963, 77 FR 18700, Mar. 28, 2012] | (a) This subpart applies to each vessel operated on waters subject to the jurisdiction of the United States and on the high seas beyond the territorial seas for vessels owned in the United States that: (1) Is operated by its operator for recreational purposes; or (2) Is required to be numbered under this part. (b) This subpart does not apply to a vessel subject to inspection under Title 46 U.S.C. Chapter 33. | |||
| 33:33:2.0.1.8.37.3.228.2 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | C | Subpart C—Casualty and Accident Reporting | § 173.53 Immediate notification of death or disappearance. | USCG | (a) When, as a result of an occurrence that involves a vessel or its equipment, a person dies or disappears from a vessel, the operator shall, without delay, by the quickest means available, notify the nearest reporting authority listed in appendix A of this part of: (1) The date, time, and exact location of the occurrence; (2) The name of each person who died or disappeared; (3) The number and name of the vessel; and (4) The names and addresses of the owner and operator. (b) When the operator of a vessel cannot give the notice required by paragraph (a) of this section, each person on board the vessel shall notify the casualty reporting authority or determine that the notice has been given. | ||||
| 33:33:2.0.1.8.37.3.228.3 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | C | Subpart C—Casualty and Accident Reporting | § 173.55 Report of casualty or accident. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by CGD 76-155, 44 FR 5308, Jan. 25, 1979; CGD 82-015, 54 FR 5610, Feb. 6, 1989; USCG-1999-6094, 66 FR 21675, May 1, 2001; 66 FR 33845, June 26, 2001; USCG-1999-6094, 67 FR 14645, Mar. 27, 2002] | (a) The operator of a vessel shall submit the casualty or accident report prescribed in § 173.57 to the reporting authority prescribed in § 173.59 when, as a result of an occurrence that involves the vessel or its equipment: (1) A person dies; (2) A person is injured and requires medical treatment beyond first aid; (3) Damage to vessels and other property totals $2,000 or more or there is a complete loss of any vessel; (4) A person disappears from the vessel under circumstances that indicate death or injury. (b) A report required by this section must be made: (1) Within 48 hours of the occurrence if a person dies within 24 hours of the occurrence; (2) Within 48 hours of the occurrence if a person is injured and requires medical treatment beyond first aid, or disappears from a vessel; and (3) Within 10 days of the occurrence or death if an earlier report is not required by this paragraph. (c) When the operator of a vessel cannot submit the casualty or accident report required by paragraph (a) of this section, the owner shall submit the casualty or accident report. | |||
| 33:33:2.0.1.8.37.3.228.4 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | C | Subpart C—Casualty and Accident Reporting | § 173.57 Contents of report. | USCG | [USCG-2003-14963, 77 FR 18700, Mar. 28, 2012, as amended at USCG-2021-0348, 87 FR 3223, Jan. 21, 2022] | (a) Each report required by § 173.55 of this subpart must be in writing, dated upon completion, and signed by the person who prepared it. (b) Each report must contain, if available, at least the following information about the casualty or accident: (1) Number and name of each vessel involved; (2) Name and address of each owner of each vessel involved; (3) Name of the nearest city or town, the county, the State, and the body of water; (4) Time and date the casualty or accident occurred; (5) Location on the water; (6) Visibility, weather, and water conditions; (7) Estimated air and water temperatures; (8) Name, address, age, or date of birth, telephone number, vessel operating experience, and boating safety training of the operator making the report; (9) Name and address of each operator of each vessel involved; (10) Number of persons onboard or towed on skis by each vessel; (11) Name, address, and date of birth of each person injured or killed; (12) Cause of each death; (13) Weather forecasts available to and weather reports used by the operator before and during the use of the vessel; (14) Name and address of each owner of property involved; (15) Availability and use of personal flotation devices; (16) Type and number of each fire extinguisher used; (17) Nature and extent of each injury; (18) Description of all property damage and vessel damage with an estimate of the cost of all repairs; (19) Description of each equipment failure that caused or contributed to the cause of the casualty; (20) Description of the vessel casualty or accident; (21) Type of vessel operation (cruising, drifting, fishing, hunting, skiing, racing, or other), and the type of accident (capsizing, sinking, fire, explosion, or other); (22) Opinion of the person making the report as to the cause of the casualty, including whether or not alcohol or drugs, or both, was a cause of or contributed to causing the casualty. (23) Characteristics of the reporting operator's vessel, including— (i) Make; (ii) Model; (iii) Type:… | |||
| 33:33:2.0.1.8.37.3.228.5 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | C | Subpart C—Casualty and Accident Reporting | § 173.59 Where to submit report. | USCG | A report required by § 173.55 must be submitted to: (a) The reporting authority listed in appendix A of this part where the vessel number was issued, or, if the vessel has no number, where the vessel is principally used; or (b) The reporting authority where the casualty or accident occurred, if it occurred outside the State where the vessel is numbered or principally used. | ||||
| 33:33:2.0.1.8.37.4.228.1 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.71 Application for and issuance of certificate of number. | USCG | [USCG-2003-14963, 77 FR 18700, Mar. 28, 2012] | (a) The owner of a vessel to which § 173.11 of this part applies and for which a certificate of number is required may apply for that certificate to the issuing authority for the vessel's State of principal operation listed in appendix A of this part. The application must be made in the manner specified by the issuing authority and must be accompanied by payment of any fee required by the issuing authority. (b) Upon determination that the owner's application for a certificate of number complies with the requirements of paragraph (a) of this section, the issuing authority may issue a certificate of number. (c) A duplicate certificate of number may be applied for and issued as provided by paragraphs (a) and (b) of this section upon the owner's statement that the original certificate is lost or destroyed. | |||
| 33:33:2.0.1.8.37.4.228.2 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.73 [Reserved] | USCG | |||||
| 33:33:2.0.1.8.37.4.228.3 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.75 Temporary certificate. | USCG | A temporary certificate valid for not more than 60 days after it is issued may be issued by an issuing authority pending the issue of a certificate of number. A temporary certificate is not valid after the date that the owner receives the certificate of number from the issuing authority. | ||||
| 33:33:2.0.1.8.37.4.228.4 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.77 Validity of certificate of number. | USCG | [CGD 72-54R, 37 FR 21399, Oct. 7, 1972, as amended by USCG-2003-15404, 68 FR 37742, June 25, 2003; USCG-2003-14963, 77 FR 18701, Mar. 28, 2012] | (a) Except as provided in paragraphs (b), (c), (d), and (e) of this section, a certificate of number is valid until the date of expiration prescribed by the issuing authority. (b) A certificate of number issued by an issuing authority is invalid after the date upon which: (1) The vessel is documented or required to be documented under Part 67 of Title 46, Code of Federal Regulations; (2) The person whose name appears on the certificate of number as owner of the vessel transfer all of his or her ownership in the vessel; or (3) The vessel is destroyed or abandoned. (c) A certificate of number issued by an issuing authority is invalid if: (1) The application for the certificate of number contains a false or fraudulent statement; or (2) The fees for the issuance of the certificate of number are not paid. (d) A certificate of number is invalid 60 days after the day on which the vessel is no longer principally operated in the State where the certificate was issued. (e) The certificate of number is invalid when the person whose name appears on the certificate involuntarily loses his or her interest in the numbered vessel by legal process. | |||
| 33:33:2.0.1.8.37.4.228.5 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.79 Expiration of Coast Guard certificate of number. | USCG | A certificate of number issued by the Coast Guard expires 3 years from the date it is issued. | ||||
| 33:33:2.0.1.8.37.4.228.6 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.81 Coast Guard forms for numbering and casualty reporting. | USCG | (a) In a State where the Coast Guard is the issuing authority, the following Coast Guard forms must be used: (1) Each application for a certificate of number or renewal must be made on two-part Form CG-3876 and 3876A, Application for Number and Temporary Certificate. (2) Each notification required by § 173.29(b) must be made on Form CG-2921, Notification of Change in Status of Vessel. (3) Each notification required by § 173.29(a) must be made on Form CG-3920, Change of Address Notice. (4) Each notification required by § 173.29(c) must be made in writing. (5) Each application for a duplicate certificate of number must be made on two-part Form CG-3919 and CG-3919A, Application for Duplicate Certificate of Number and Temporary Duplicate Certificate. (6) Each vessel casualty required to be reported by § 173.55 must be made on Form CG-3865. (b) Each surrender of a certificate of number required by § 173.31 may be made in any form but must contain a written statement as to why the certificate is being surrendered. | ||||
| 33:33:2.0.1.8.37.4.228.7 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.83 Availability of Coast Guard forms. | USCG | In a State where the Coast Guard is the issuing authority, forms required by § 173.81 are available at all manned Coast Guard shore units, except light and loran stations and except for Form CG-3865, at all first- and second-class and some third- and fourth-class post offices. | ||||
| 33:33:2.0.1.8.37.4.228.8 | 33 | Navigation and Navigable Waters | I | S | 173 | PART 173—VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING | D | Subpart D—Issue of Certificate of Number | § 173.85 Fees levied by the Coast Guard. | USCG | [USCG-1998-3386, 64 FR 36243, July 6, 1999] | (a) In a State where the Coast Guard is the issuing authority, the fees for issuing certificates of number are: (1) Original or transferred certificate of number and two validation stickers—$24. (2) Renewed certificate of number and two validation stickers—$16. (3) Duplicate certificate of number—$9. (4) Replacement of lost or destroyed validation stickers—$9. (b) Fees are payable by check or money-order made payable to the “U.S. Coast Guard”; by major credit card (MasterCard or Visa); or, when the owner applies in person, in cash. | |||
| 40:40:26.0.1.1.22.0.19.1 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.1 Applicability. | EPA | These procedures govern any proceeding to rescind a State's primary enforcement responsibility for pesticide use violations conducted under section 27(b) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA), 7 U.S.C. 136 et seq. | ||||||
| 40:40:26.0.1.1.22.0.19.2 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.2 Definitions. | EPA | For purposes of this part: (a) Administrator means the Administrator of the United States Environmental Protection Agency or his delegate. (b) Notice of intent to rescind means a notice to a State issued under § 173.3 which initiates a proceeding to rescind the State's primary enforcement responsibility for pesticide use violations. (c) State means the agency or agencies primarily responsible for enforcing pesticide use laws or regulations within the State or jurisdiction undergoing rescission proceedings. (d) Party to the proceeding shall mean the State or the Agency's Office of Enforcement. (e) Presiding Officer means an attorney appointed by the Administrator to conduct the rescission proceeding. The Presiding Officer shall be an employee or representative of the Agency and shall not have had prior direct connection with the specific proceeding except in circumstances where subsequent hearings are in order. | ||||||
| 40:40:26.0.1.1.22.0.19.3 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.3 Initiation of rescission proceedings. | EPA | (a) Whenever the Administrator determines that a State having primary enforcement responsibility for pesticide use violations is not carrying out such responsibility, or cannot carry out such responsibility due to the lack of adequate legal authority, the Administrator shall notify the State in writing of his intent to rescind its primary enforcement responsibility, in whole or in part, by serving upon the State a notice of intent to rescind. (b) The notice of intent to rescind shall: (1) Specify those aspects of the State's pesticide use enforcement program determined to be inadequate; (2) Specify the facts which underlie the findings contained in the rescission notice; (3) Have attached thereto copies of any relevant documents discoverable under the Federal Rules of Civil Procedure and the Freedom of Information Act which contain data relied upon by the Administrator in making his decision to issue the notice; (4) Have attached thereto a copy of this part; and (5) Be sent to the State by certified mail, return receipt requested. (c) The State may respond in writing to the findings specified in the notice of intent to rescind. | ||||||
| 40:40:26.0.1.1.22.0.19.4 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.4 Informal conference and settlement. | EPA | (a) After receipt of a notice of intent to rescind, the State may request that an informal conference be held between appropriate State and EPA officials to discuss the findings made in the notice of intent to rescind. The informal conference shall then be held in the State. If the Administrator finds, on the basis of information submitted by the State at the conference, that the deficiencies specified in the notice did not exist or were corrected by the State, the Administrator shall issue an order withdrawing the notice of intent to rescind and terminating the rescission proceeding. (b) At any time after receipt of a notice of intent to rescind and before the issuance of a final order, the State and EPA may resolve the issues raised in the notice by agreement. Any settlement agreement shall be in writing and signed by the parties and shall: (1) Detail the deficiencies found in the State program; (2) Specify the steps the State has taken or will take to remedy the deficiencies; and (3) Set forth a precise schedule for each remedial action yet to be initiated. (c) If a written agreement is signed by the parties, the Administrator shall issue an order withdrawing the notice of intent to rescind and terminating the rescission proceeding. If the State does not comply with the terms of the settlement agreement, the Administrator may reissue the notice of intent to rescind. | ||||||
| 40:40:26.0.1.1.22.0.19.5 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.5 Request for hearing. | EPA | A State may request a hearing before a Presiding Officer not later than sixty (60) days after receipt of a notice of intent to rescind. | ||||||
| 40:40:26.0.1.1.22.0.19.6 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.6 Publication of the notice; scheduling the hearing. | EPA | (a) If the Administrator has not issued an order terminating the rescission proceeding within sixty (60) days after service of the notice of intent to rescind upon the State, the Administrator shall publish the notice of intent to rescind in the Federal Register. The Administrator may modify the original notice of intent to rescind before its publication by deleting those deficiencies listed in the original notice which have been corrected or which were shown not to have existed. The public may submit comments upon the matters specified in the published notice of intent to rescind within the time specified therein. (b) Concurrently with the publication of the notice of intent to rescind, the Administrator shall schedule a hearing in the State if one has been requested by the State. The date, time, and location of the hearing shall be published in the Federal Register along with the notice of intent to rescind. (c) If a hearing is requested and the Administrator has not issued an order terminating the rescission proceeding, the Administrator shall provide for a hearing as scheduled. Representatives of the State, EPA, and the public may present evidence at the hearing. The Administrator shall appoint a Presiding Officer who shall preside over the hearing and make a recommended decision regarding the adequacy of the State's pesticide use enforcement program. The Administrator, after consultation with the State, may prescribe additional procedures governing the conduct of the hearing. (d) If a termination order is issued or the hearing is rescheduled after the notice of intent to rescind is published in the Federal Register, such order or notice rescheduling the hearing shall also be published in the Federal Register. | ||||||
| 40:40:26.0.1.1.22.0.19.7 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.7 Hearing and recommended decision. | EPA | (a) The Presiding Officer shall: (1) Conduct a fair and impartial hearing, without unnecessary delay; (2) Ensure that the facts are fully elicited; and (3) Consider all evidence, comment, and argument which is submitted by persons who will be affected by the outcome of the proceeding and which is not irrelevant, immaterial, unduly repetitious, or otherwise unreliable or of little probative value. The Presiding Officer may require any prospective witness to make available, in advance of the hearing, a brief summary of his or her testimony. (b) If, following the close of the hearing, the Presiding Officer finds that the State has corrected, or has agreed in writing to correct, the deficiencies specified in the notice of intent to rescind or has shown that such deficiencies do not exist, the Presiding Officer shall issue a decision recommending that the notice of intent to rescind be withdrawn and that the rescission proceeding be terminated. (c) If, following the close of the hearing, the Presiding Officer finds that the State has not corrected the deficiencies in its program, the Presiding Officer shall issue a decision recommending that the State's primary enforcement responsibility for pesticide use violations be rescinded in whole or in part. (d) The recommended decision of the Presiding Officer shall become final Agency action forty-five (45) days after its service upon the parties and without further proceedings unless (1) an appeal to the Administrator is taken from it by a party to the proceeding, or (2) the Administrator elects, sua sponte, to review the recommended decision. | ||||||
| 40:40:26.0.1.1.22.0.19.8 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.8 Final order. | EPA | (a) If the State does not request a hearing within the sixty-day time period and the Administrator has not issued an order withdrawing the notice of intent to rescind, the Administrator shall issue a final order as soon as practicable after the time for public comment on the notice of intent to rescind has elapsed. The final order shall either withdraw the notice of intent to rescind and terminate the proceeding or rescind, in whole or in part, the State's primary enforcement responsibility for pesticide use violations. (b) If a hearing has been held and the Presiding Officer has made a recommended decision, then either the Office of Enforcement or the State may appeal the recommended decision to the Administrator or the Administrator may elect to review the recommended decision on his own initiative. (c) After an appeal or sua sponte review the Administrator shall issue a final order terminating the rescission proceeding or rescinding, in whole or in part, the State's primary enforcement responsibility for pesticide use violations. (d) In no event may the Administrator issue his final decision sooner than ninety (90) days after service of the notice of intent to rescind on a State. (e) Any final order, or a recommended decision which becomes a final order under § 173.7(c), shall be published in the Federal Register. | ||||||
| 40:40:26.0.1.1.22.0.19.9 | 40 | Protection of Environment | I | E | 173 | PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS | § 173.9 Judicial review. | EPA | The State may appeal an order rescinding, in whole or in part, its primary enforcement responsibility for pesticide use violations to the appropriate federal court pursuant to section 16 of FIFRA. | ||||||
| 46:46:7.0.1.2.8.1.59.1 | 46 | Shipping | I | S | 173 | PART 173—SPECIAL RULES PERTAINING TO VESSEL USE | A | Subpart A—General | § 173.001 Applicability. | USCG | Each vessel that is engaged in one of the following activities must comply with the applicable provisions of this part: (a) Lifting. (b) Training (schoolship). (c) Oceanographic research. (d) Towing. | ||||
| 46:46:7.0.1.2.8.2.59.1 | 46 | Shipping | I | S | 173 | PART 173—SPECIAL RULES PERTAINING TO VESSEL USE | B | Subpart B—Lifting | § 173.005 Specific applicability. | USCG | [CGD 79-023, 48 FR 51045, Nov. 4, 1983, as amended by CGD 85-080, 61 FR 945, Jan. 10, 1996] | This subpart applies to each vessel that— (a) Is equipped to lift cargo or other objects; and (b) Has a maximum heeling moment due to hook load greater than or equal to— (0.67)(W)(GM)(F/B) in meter-metric tons (foot-long tons), where— W = displacement of the vessel with the hook load included in metric (long) tons. GM = metacentric height with hook load included in meters (feet). F = freeboard to the deck edge amidships in meters (feet). B = beam in meters (feet). (0.67)(W)(GM)(F/B) in meter-metric tons (foot-long tons), where— W = displacement of the vessel with the hook load included in metric (long) tons. GM = metacentric height with hook load included in meters (feet). F = freeboard to the deck edge amidships in meters (feet). B = beam in meters (feet). | |||
| 46:46:7.0.1.2.8.2.59.2 | 46 | Shipping | I | S | 173 | PART 173—SPECIAL RULES PERTAINING TO VESSEL USE | B | Subpart B—Lifting | § 173.007 Location of the hook load. | USCG | When doing the calculations required in this subpart, the hook load must be considered to be located at the head of the crane. | ||||
| 46:46:7.0.1.2.8.2.59.3 | 46 | Shipping | I | S | 173 | PART 173—SPECIAL RULES PERTAINING TO VESSEL USE | B | Subpart B—Lifting | § 173.010 Definitions. | USCG | As used in this part— (a) Hook load means the weight of the object lifted by the crane. (b) Crane radius means the distance illustrated in Figure 173.010. | ||||
| 46:46:7.0.1.2.8.2.59.4 | 46 | Shipping | I | S | 173 | PART 173—SPECIAL RULES PERTAINING TO VESSEL USE | B | Subpart B—Lifting | § 173.020 Intact stability standards: Counterballasted and non-counterballasted vessels. | USCG | [CGD 79-023, 48 FR 51045, Nov. 4, 1983, as amended by CGD 85-080, 61 FR 945, Jan. 10, 1996] | (a) Except as provided in paragraph (c) of this section, each vessel that is not equipped to counter-ballast while lifting must be shown by design calculations to comply with this section in each condition of loading and operation and at each combination of hook load and crane radius. (b) Each vessel must have a righting arm curve with the following characteristics: (1) If the vessel operates in protected or partially protected waters, the area under the righting arm curve up to the smallest of the following angles must be at least 10 foot-degrees (3.05 meter-degrees): (i) The angle corresponding to the maximum righting arm. (ii) The downflooding angle. (iii) 40 degrees. (2) If the vessel operates in exposed waters, the area under the righting arm curve up to the smallest of the following angles must be at least 15 foot-degrees (4.57 meter-degrees): (i) The angle corresponding to the maximum righting arm. (ii) The downflooding angle. (iii) 40 degrees. (c) If the vessel's hull proportions fall within all three of the following limits, in lieu of complying with paragraph (b) of this section, the vessel owner may demonstrate in the presence of the OCMI that the vessel will not heel beyond the limits specified in paragraph (d) of this section: (1) Beam to depth—3.40 to 4.75. (2) Length to beam—3.20 to 4.50. (3) Draft to depth—0.60 to 0.85. (d) For the purpose of paragraph (c) of this section, the following limits of heel apply with the vessel at its deepest operating draft: (1) Protected and partially protected waters and Great Lakes in summer—heel to main deck immersion or bilge emergence, whichever occurs first. (2) Exposed waters and Great Lakes in winter—heel permitted to one-half of the freeboard or one-half of the draft, whichever occurs first. | |||
| 46:46:7.0.1.2.8.2.59.5 | 46 | Shipping | I | S | 173 | PART 173—SPECIAL RULES PERTAINING TO VESSEL USE | B | Subpart B—Lifting | § 173.025 Additional intact stability standards: Counterballasted vessels. | USCG | [CGD 79-023, 48 FR 51045, Nov. 4, 1983, as amended by CGD 85-080, 61 FR 945, Jan. 10, 1996] | (a) Each vessel equipped to counterballast while lifting must be shown by design calculations to be able to withstand the sudden loss of the hook load, in each condition of loading and operation and at each combination of hook load and crane radius. (b) When doing the calculations required by this section, the hook load and counterballast heeling arms and vessel righting arms, as plotted on graph 173.025, must define areas that satisfy the following equation: Area II >Area I + K Where— (1) K = O for operation on protected waters and 7 foot-degrees (2.13 meter-degrees) for operation on partially protected and exposed waters. (2) Areas I and II are shown on graph 173.025. Where— (1) K = O for operation on protected waters and 7 foot-degrees (2.13 meter-degrees) for operation on partially protected and exposed waters. (2) Areas I and II are shown on graph 173.025. (c) Each heeling arm curve must be defined by— HA = HAO cos (T) Where— HA = heeling arm. HAO = heeling arm at 0 degrees of heel. T = angle of heel. Where— HA = heeling arm. HAO = heeling arm at 0 degrees of heel. T = angle of heel. Where— GZ(1) is the righting arm curve at the displacement corresponding to the vessel without hooking load. GZ(2) is the righting arm curve at the displacement corresponding to the vessel with hook load. HA(1) is the heeling arm curve due to the combined heeling moments of the hook load and the counterballast at the displacement with hook load. HA(2) is the heeling arm due to the counterballast at the displacement without hook load. Theta(c) is the angle of static equilibrium due to the combined hook load and counterballast heeling moments. Theta(f) is the downflooding angle on the counterballasted side of the vessel. Where— GZ(1) is the righting arm curve at the displacement corresponding to the vessel without hooking load. GZ(2) is the righting arm curve at the displacement corresponding to the vessel with hook load. HA(1) is the heeling arm curve due to the combined heeling … |
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);