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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:6.0.1.1.23.2.2.1 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.120 Acrylamide-acrylic acid resin. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 45 FR 38058, June 6, 1980] | Acrylamide-acrylic acid resin (hydrolized polyacrylamide), only for the purposes of this section as described below, may be safely used in accordance with the following prescribed conditions: (a) The additive is produced by 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. (b) The additive meets the following specifications: (1) A minimum molecular weight of 3 million. (2) Viscosity range: 3,000 to 6,000 centipoises at 77 °F in a 1 percent aqueous solution as determined by LVF Brookfield Viscometer or equivalent using a number 6 spindle at 20 r.p.m. (3) Residual acrylamide: Not more than 0.05 percent. (c) It is used as a thickener and suspending agent in nonmedicated aqueous suspensions intended for addition to animal feeds. | |||
| 21:21:6.0.1.1.23.2.2.10 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.225 1,3-Butylene glycol. | FDA | [53 FR 40061, Oct. 13, 1988] | The food additive 1,3-butylene glycol (1,3-butanediol) may be safely used in accordance with the following prescribed conditions: (a) It complies with the specifications in § 173.220(a) of this chapter. (b) It is intended for use in swine feed as a source of energy. (c) It is to be thoroughly mixed into feed at levels not to exceed 9 percent of the dry matter of the total ration. (d) 1,3-Butylene glycol should be mixed in feed with equipment adapted for the addition of liquids, and the feed should be mixed not less than 5 minutes after its addition. | |||
| 21:21:6.0.1.1.23.2.2.11 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.230 Calcium formate. | FDA | [88 FR 87671, Dec. 19, 2023] | The food additive calcium formate may be safely used in the manufacture of complete swine and poultry feeds in accordance with the following prescribed conditions: (a) The additive is manufactured by the reaction of butyraldehyde, formaldehyde, calcium hydroxide, and formic acid in water followed by purification and dried to produce a powder consisting of not less than 99.0 percent calcium formate (CAS 544-17-2). The additive meets the following specifications: (1) The additive consists of minimum 30.5 percent calcium and minimum 68.5 percent formate. (2) Trimethylolpropane (TMP) not to exceed 125 parts per million. (b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine or poultry feeds at levels not to exceed 1.2 percent of the complete feed. (c) To ensure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (d) To ensure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain: (1) The name of the additive. (2) Adequate directions for use including a statement that calcium formate must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing calcium formate. (3) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (e) To ensure safe use of the additive, in addition to the other information required by the act and paragraph (d) of this section, the label and labeling shall contain: (1) Appropriate warnings and safety precautions concerning calcium formate. (2) Statements identifying calcium formate as a possible severe irritant. (3) Information… | |||
| 21:21:6.0.1.1.23.2.2.12 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.240 Calcium periodate. | FDA | The food additive calcium periodate may be safely used in accordance with the following prescribed conditions: (a) The additive is produced by reacting calcium iodate with calcium hydroxide or calcium oxide to form a substance consisting of not less than 60 percent by weight of penta calcium orthoperiodate containing 28 to 31 percent by weight of iodine. (b) It is used or intended for use in salt for livestock as a source of iodine. | ||||
| 21:21:6.0.1.1.23.2.2.13 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.260 Calcium silicate. | FDA | Calcium silicate, including synthetic calcium silicate, may be safely used as an anticaking agent in animal feed, provided that the amount of calcium silicate does not exceed 2 percent. | ||||
| 21:21:6.0.1.1.23.2.2.14 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.280 Feed-grade calcium stearate and sodium stearate. | FDA | [63 FR 8573, Feb. 20, 1998] | Feed-grade calcium stearate and sodium stearate may be safely used in an animal feed in accordance with the following prescribed conditions: (a) Feed-grade calcium stearate and sodium stearate are the calcium or sodium salts of a fatty acid mixture that is predominately stearic acid. Associated fatty acids, including palmitic acid and minor amounts of lauric, myristic, pentadecanoic, margaric, arachidic, and other fatty acids may be contained in the mixture, but such associated fatty acids in aggregate do not exceed 35 percent by weight of the mixture. The fatty acids may be derived from feed-grade fats or oils. (b) The additives meet the following specifications: (1) Unsaponifiable matter does not exceed 2 percent. (2) They are free of chick-edema factor. (c) The additives are manufactured so that in aqueous solution they are exposed for 1 hour or longer to temperature in excess of 180 °F. (d) They are used as anticaking agents in animal feeds in accordance with current good manufacturing practices. | |||
| 21:21:6.0.1.1.23.2.2.15 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.300 Choline xanthate. | FDA | Choline xanthate may be safely used as a component of animal feed as an added source of choline to supplement the diets of poultry, ruminants, and swine in accordance with good feeding practice. | ||||
| 21:21:6.0.1.1.23.2.2.16 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.304 Chromium propionate. | FDA | [81 FR 35611, June 3, 2016, as amended at 85 FR 14566, Mar. 13, 2020; 85 FR 48650, Aug. 12, 2020; 89 FR 5768, Jan. 30, 2024] | The food additive chromium propionate may be safely used in animal feed as a source of supplemental chromium in accordance with the following prescribed conditions: (a) The additive is manufactured by the reaction of a chromium salt with propionic acid, at an appropriate stoichiometric ratio, to produce triaqua-(mu 3 -oxo) hexakis (mu 2 -propionato- O,O ′) trichromium propionate with the empirical formula, [Cr 3 (O)(CH 3 CH 2 CO 2 ) 6 (H 2 O) 3 ]CH 3 CH 2 CO 2 . (b) The additive is added to feed as follows: (1) In complete feed for broiler chickens and growing turkeys at a level not to exceed 0.2 milligrams (mg) of chromium from chromium propionate per kilogram feed. (2) In feed for horses at a level not to exceed an intake of 4 mg of chromium from chromium propionate per horse per day. (c) The additive meets the following specifications: (1) Total chromium content, 8 to 10 percent. (2) Hexavalent chromium content, less than 2 parts per million (ppm). (3) Arsenic, less than 1 ppm. (4) Cadmium, less than 1 ppm. (5) Lead, less than 0.5 ppm. (6) Mercury, less than 0.5 ppm. (7) Viscosity, not more than 2,000 centipoise. (d) The additive shall be incorporated into feed as follows: (1) It shall be incorporated into each ton of feed by adding no less than one pound of a premix containing no more than 181.4 milligrams of added chromium from chromium propionate per pound. (2) The premix manufacturer shall follow good manufacturing practices in the production of chromium propionate premixes. Inventory, production, and distribution records must provide a complete and accurate history of product production. (3) Chromium from all sources of supplemental chromium cannot exceed: (i) A level of 0.2 ppm in complete feed for broiler chickens and growing turkeys. (ii) An intake of 4 mg per horse per day. (e) To assure safe use of the additive in addition to the other information required by the Federal Food, Drug, and Cosmetic Act: (1) The label and labeling of the additive, any feed premix, and feed shall conta… | |||
| 21:21:6.0.1.1.23.2.2.17 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.310 Crambe meal, heat toasted. | FDA | [46 FR 30082, June 5, 1981] | (a) The additive is the seed meal of Crambe abyssinica obtained after the removal of oil from the seed and hull. The oil may be removed by pre-press solvent extraction or by solvent extraction alone. The resulting seed meal is heat toasted. (b) The additive conforms to the following percent-by-weight specifications: moisture, not more than 11 percent; oil, not more than 4 percent; crude protein, not less than 24 percent; crude fiber, not more than 26 percent; glucosinolate calculated as epi-progoitrin, not more than 4 percent; goitrin, not more than 0.1 percent; nitrile calculated as 1-cyano-2-hydroxy-3-butene, not more than 1.4 percent. At least 50 percent of the nitrogen shall be soluble in 0.5 M sodium chloride. Myrosinase enzyme activity shall be absent. (c) The additive is used or intended for use in the feed of feedlot cattle as a source of protein in an amount not to exceed 4.2 percent of the total ration. | |||
| 21:21:6.0.1.1.23.2.2.18 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.320 Diammonium phosphate. | FDA | The food additive diammonium phosphate may be safely used in ruminant feed in accordance with the following prescribed conditions: (a) The food additive is the product resulting from the neutralization of feeding-phosphoric-acid or defluorinated wet-process phosphoric acid with anhydrous ammonia. It contains not less than 106.25 percent equivalent crude protein (nitrogen × 6.25) and 20 percent phosphorus. It contains not more than the following: 1 part fluorine to 100 parts phosphorus. 75 parts per million or arsenic (as As). 30 parts per million of heavy metals, as lead (Pb). 1 part fluorine to 100 parts phosphorus. 75 parts per million or arsenic (as As). 30 parts per million of heavy metals, as lead (Pb). (b) It is used in ruminant feeds as a source of phosphorus and nitrogen in an amount that supplies not more than 2 percent of equivalent crude protein in the total daily ration. (c) To assure safe use of the additive, the label and labeling of the additive and that of any feed additive supplement, feed additive concentrate, feed additive premix, or complete feed prepared therefrom shall contain, in addition to other information required by the act, the following: (1) The name of the additive. (2) The maximum percentage of equivalent crude protein from the nonprotein nitrogen. (3) If the feed additive premix, feed additive concentrate, or feed additive supplement contains more than 2 percent equivalent crude protein from diammonium phosphate, adequate directions for use and a prominent statement, “Warning—This feed should be used only in accordance with directions furnished on the label.” | ||||
| 21:21:6.0.1.1.23.2.2.19 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.340 Diatomaceous earth. | FDA | (a) Identity. The additive consists of siliceous skeletal material derived from various species of diatoms. (b) Specifications. The additive shall conform to the following specifications: Lead, not more than 15 parts per million. Arsenic (as As), not more than 20 parts per million Fluorine, not more than 600 parts per million. Lead, not more than 15 parts per million. Arsenic (as As), not more than 20 parts per million Fluorine, not more than 600 parts per million. (c) Uses. It is used or intended for use as an inert carrier or anticaking agent in animal feeds in an amount not to exceed 2 percent by weight of the total ration. | ||||
| 21:21:6.0.1.1.23.2.2.2 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.130 Aminoglycoside 3′-phospho- transferase 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. | |||
| 21:21:6.0.1.1.23.2.2.20 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.360 Disodium EDTA. | FDA | The food additive disodium EDTA (disodium ethylenediaminetetraace- tate) may be safely used in animal feeds, in accordance with the following prescribed conditions: (a) The food additive contains a minimum of 99 percent disodium ethylenediaminetetraacetate dihydrate (C 10 H 14 O 8 N 2 Na 2 · 2H 2 O). (b) It is used to solubilize trace minerals in aqueous solutions, which are then added to animal feeds. (c) It is used or intended for use in an amount not to exceed 240 parts per million of the additive in finished feed. (d) To assure safe use of the additive the label and labeling shall bear: (1) The name of the additive; and (2) Adequate mixing directions to ensure that the chelated trace-mineral mix is uniformly blended throughout the feed. | ||||
| 21:21:6.0.1.1.23.2.2.21 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.380 Ethoxyquin in animal feeds. | FDA | Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be safely used in animal feeds, when incorporated therein in accordance with the following prescribed conditions. (a) It is intended for use only: (1) As a chemical preservative for retarding oxidation of carotene, xanthophylls, and vitamins A and E in animal feed and fish food and, (2) as an aid in preventing the development of organic peroxides in canned pet food. (b) The maximum quantity of the additive permitted to be used and to remain in or on the treated article shall not exceed 150 parts per million. (c) To assure safe use of the additive, the label and labeling of the food additive container and that of any intermediate premixes prepared therefrom shall contain, in addition to other information required by the act: (1) The name of the additive, ethoxyquin. (2) A statement of the concentration or strength contained therein. (3) Adequate use directions to provide for a finished article with the proper concentration of the additive as provided in paragraph (b) of this section, whether or not intermediate premixes are to be used. (d) The label of any animal feed containing the additive shall, in addition to the other information required by the act, bear the statement “Ethoxyquin, a preservative” or “Ethoxyquin added to retard the oxidative destruction of carotene, xanthophylls, and vitamins A and E.” | ||||
| 21:21:6.0.1.1.23.2.2.22 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.400 Ethoxyquin in certain dehydrated forage crops. | FDA | Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be safely used in the dehydrated forage crops listed in paragraph (a) of this section when incorporated therein in accordance with the conditions prescribed in this section: (a) It may be added to dehydrated forage prepared from: or any mixture of such forage crops, for use only as an animal feed. (b) Such additive is used only as a chemical preservative for the purpose of retarding oxidative destruction of naturally occurring carotenes and vitamin E in the forage crops. (c) It is added to the dehydrated forage crops in an oil mixture containing only suitable animal or suitable vegetable oil, prior to grinding and mixing. (d) The maximum quantity of the additive permitted to be used and to remain in or on the dehydrated forage crop shall not exceed 150 parts per million. (e) To assure the safe use of the additive, the label of the market package shall contain, in addition to other information required by the act: (1) The name of the additive as specified in this section. (2) Directions for the incorporation of the additive in the forage crops, as specified in paragraph (c) of this section, with the directive that only suitable animal or suitable vegetable oils are to be used in the oil mix. (f) The label of any dehydrated forage crops treated with the additive or the label of an animal-feed supplement containing such treated forage crops, shall, in addition to other information required by the act, bear the following statements: (1) “Ethoxyquin, a preservative,” or “Ethoxyquin added to retard the oxidative destruction of carotene and vitamin E.” (2) The statement “For use in animal feed only.” | ||||
| 21:21:6.0.1.1.23.2.2.23 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.420 Ethyl cellulose. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 89 FR 48508, June 7, 2024] | The food additive ethyl cellulose may be safely used in animal feed in accordance with the following prescribed conditions: (a) The food additive is a cellulose ether containing ethoxy (OC 2 H 5 ) groups attached by an ether linkage and containing on an anhydrous basis not more than 2.6 ethoxy groups per anhydroglucose unit. (b) It is used or intended for use: (1) As a binder or filler in dry vitamin preparations to be incorporated into animal feed. (2) As a matrix scaffolding for tracers, and the ethyl cellulose content shall not exceed 80 percent of the tracer. | |||
| 21:21:6.0.1.1.23.2.2.24 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.440 Ethylene dichloride. | FDA | The food additive ethylene dichloride may be safely used in the manufacture of animal feeds in accordance with the following prescribed conditions: (a) It is used as a solvent in the extraction processing of animal byproducts for use in animal feeds. (b) The maximum quantity of the additive permitted to remain in or on the extracted byproducts shall not exceed 300 parts per million. (c) The extracted animal byproduct is added as a source of protein to a total ration at levels consistent with good feeding practices, but in no event at levels exceeding 13 percent of the total ration. | ||||
| 21:21:6.0.1.1.23.2.2.25 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.450 Fermented ammoniated condensed whey. | FDA | [43 FR 33708, July 1, 1978, as amended at 46 FR 49115, Oct. 6, 1981; 89 FR 67856, Aug. 22, 2024] | (a) Identity. The product is produced by the Lactobacillus delbrueckii fermentation of whey with the addition of ammonia. (b) Specifications. The product contains 35 to 55 percent crude protein and not more than 42 percent equivalent crude protein from nonprotein nitrogen sources. (c) Uses. The product is used as a source of protein and nonprotein nitrogen for cattle. (d) Limitations. (1) Store in a closed vented tank equipped for agitation. Agitate 5 minutes before using. Do not store at temperature above 110 °F (43 °C). (2) The maximum level of use of fermented ammoniated condensed whey and equivalent crude protein from all other added forms of nonprotein nitrogen shall not exceed 30 percent of the dietary crude protein. (3) The additive may be used as follows: (i) Mixed with grain, roughage, or grain and roughage prior to feeding. (ii) As a component of free-choice liquid feeds, used to supplement the diets of cattle fed other sources of nutrients, fermented ammoniated condensed whey shall not exceed 80 percent of the free-choice liquid feed. (e) Labeling. The label shall bear, in addition to other information required by the act: (1) The name of the additive. (2) The maximum percentage of equivalent crude protein from nonprotein nitrogen. (3) Adequate directions for use in accordance with the provisions in paragraph (d) of this section. | |||
| 21:21:6.0.1.1.23.2.2.26 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.460 Formaldehyde. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 61 FR 15704, Apr. 9, 1996; 63 FR 53580, Oct. 6, 1998; 68 FR 65633, Nov. 21, 2003; 88 FR 45066, July 14, 2023] | The food additive formaldehyde may be safely used in the manufacture of animal feeds in accordance with the following conditions: (a) The additive is used, or intended for use, to improve the handling characteristics of fat by producing a dry, free-flowing product, as follows: (1) For animal fat in combination with certain oilseed meals, as a component of dry, nonpelletted feeds for beef and nonlactating dairy cattle. (i) An aqueous blend of soybean and sunflower meals in a ratio of 3:1, respectively, is mixed with animal fat such that the oilseed meals and animal fat are in a ratio of 3:2. The feed ingredients are those defined by the “Official Publication” of the Association of American Feed Control Officials, Inc., 2003 ed., pp. 303, 308, and 309, 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 Assistant Secretary-Treasurer, Association of American Feed Control Officials Inc., P.O. Box 478, Oxford, IN 47971, or you may examine a copy at the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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. (ii) Formaldehyde (37 percent solution) is added to the mixture at a level of 4 percent of the dry matter weight of the oilseed meals and animal fat. This mixture, upon drying, contains not more than 1 percent formaldehyde and not more than 12 percent moisture. (iii) To assure the safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act (the act), the label and labeling of the dried mixture shall bear: (A) The name of the additive. (B) Adequate directions for use providing that the feed as consumed does … | |||
| 21:21:6.0.1.1.23.2.2.27 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.480 Formic acid. | FDA | [76 FR 7106, Feb. 9, 2011, as amended at 82 FR 52209, Nov. 13, 2017; 83 FR 20, Jan. 2, 2018; 83 FR 66618, Dec. 27, 2018] | The food additive, formic acid, may be safely used in accordance with the following conditions: (a) The additive is used as a preservative in hay crop silage in an amount not to exceed 2.25 percent of the silage on a dry weight basis or 0.45 percent when direct cut, as follows: (1) The top foot of silage stored should not contain formic acid and (2) Silage should not be fed to livestock within 4 weeks of treatment. (b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete feed for swine and poultry at levels not to exceed 1.2 percent of the complete feed. (1) The additive consists of not less than 85 percent formic acid (CAS 64-18-6). (2) The additive meets the following specifications: (i) Free methyl alcohol not to exceed 1,000 parts per million (ppm); (ii) Methyl formate not to exceed 1,000 ppm; and (iii) Moisture not to exceed 15 percent. (3) To ensure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (4) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug and Cosmetic Act, the label and labeling shall contain: (i) The name of the additive. (ii) Adequate directions for use including a statement that formic acid must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing formic acid. (iii) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (5) To ensure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act and paragraph (b)(4) of this section, the label and labeling shall contain: (i) Appropriate warnings and safety prec… | |||
| 21:21:6.0.1.1.23.2.2.28 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.485 Fumonisin esterase. | FDA | [87 FR 47344, Aug. 3, 2022, as amended at 87 FR 52682, Aug. 29, 2022] | The food additive fumonisin esterase may be safely used to degrade fumonisins in swine and poultry feed in accordance with the following prescribed conditions: (a) Fumonisin esterase, a carboxylesterase, is produced by a nontoxigenic and nonpathogenic yeast, Komagataella phaffii, genetically engineered to express the fumonisin esterase gene from the bacterium Sphingopyxis sp. Hydrolyzed fumonisin and two tricarballylic acid molecules are the reaction products of fumonisin hydrolysis by this 493 amino acid fumonisin esterase enzyme. (b) The additive shall meet the following specifications: (1) The fermentation media for the Komagataella phaffii shall not contain methanol. (2) Viable genetically engineered Komagataella phaffii shall not be present. (3) One unit of fumonisin esterase activity is defined as the amount of enzymatic activity required to release one micromole of tricarballylic acid (CAS 99-14-9) per minute from 100 micromolar fumonisin B1 in 20 millimolar Tris-hydrochloride buffer (pH 8.0) containing 0.1 milligram per milliliter of bovine serum albumin at 30 °C. (c) The additive is incorporated at a minimum of 15 units of fumonisin esterase activity per kilogram of complete feed: (1) Complete swine feeds cannot contain more than 10 parts per million of total fumonisins. (2) Complete feed for poultry being raised for slaughter cannot contain more than 50 parts per million of total fumonisins. (3) Complete feed for breeding poultry and hens laying eggs for human consumption cannot contain more than 15 parts per million of total fumonisins. (d) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act: (1) The label and labeling of the additive, any feed premix, and complete feed shall contain the common or usual name of the additive's source, dried Komagataella phaffii fermentation product. (2) The label and labeling of the additive and any feed premix shall also contain: (i) Adequate directions for use including a … | |||
| 21:21:6.0.1.1.23.2.2.29 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.490 Gamma-linolenic acid safflower meal. | FDA | [80 FR 35569, June 22, 2015] | The food additive consists of the meal obtained after the removal of most of the oil from whole seeds or partially dehulled seeds or both obtained from a Carthamus tinctorius L. safflower Centennial variety genetically engineered to express the delta-6-desaturase gene from Saprolegnia diclina Humphrey. The 453 amino acid, delta-6-desaturase enzyme converts the fatty acid linoleic acid to gamma-linolenic acid during seed development. The resulting additive may be safely used in cattle and poultry feeds in accordance with the following prescribed conditions: (a) The additive shall contain not less than 20 percent crude protein, not more than 40 percent crude fiber, not more than 10 percent moisture, and not more than 2 percent crude fat. (b) The crude fat in the additive meets the following specifications: (1) Gamma-linolenic acid content not to exceed 55 percent. (2) Total content of stearidonic acid and cis, cis-6, 9-octadecadienoic acid not to exceed a total of 0.5 percent. (3) Total content of palmitic, stearic, oleic, linoleic, and other associated fatty acids to exceed a total of 40 percent. (c) The additive is used or intended for use in cattle and poultry feeds as a source of protein in accordance with good manufacturing and feeding practices. (d) To assure safe use of the additive, in addition to the other information required by the Food, Drug, and Cosmetic Act, the label and labeling of the additive, any feed premix, or complete feed shall bear the following: (1) The name of the additive or the common name, safflower meal. (2) Adequate directions for use in cattle and poultry feeds. (e) The additive may be identified by the common or usual name, safflower meal. | |||
| 21:21:6.0.1.1.23.2.2.3 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.140 Ammoniated cottonseed meal. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 42 FR 52397, Sept. 30, 1977] | The food additive ammoniated cottonseed meal may be safely used in accordance with the following conditions: (a) The food additive is the product obtained by the treatment of cottonseed meal with anhydrous ammonia until a pressure of 50 pounds per square inch gauge is reached. (b) It is used or intended for use in the feed of ruminants as a source of protein and/or as a source of nonprotein nitrogen in an amount not to exceed 20 percent of the total ration. (c) To assure safe use, the label and labeling of the additive and of any feed additive supplement, concentrate, or premix prepared therefrom shall bear, in addition to the other information required by the act, the following: (1) The name of the additive. (2) The maximum percentage of equivalent crude protein from the nonprotein nitrogen. (3) Directions for use to provide not more than 20 percent of the additive in the total ration. (4) A statement: (i) That not more than one-third of the total protein in the feed should come from nonprotein nitrogen sources. (ii) That the additive is not to be given to debilitated or starved animals. (iii) “Warning—This feed should be used only in accordance with directions furnished on the label.” | |||
| 21:21:6.0.1.1.23.2.2.30 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.492 Gamma-linolenic acid safflower oil. | FDA | [84 FR 6675, Feb. 28, 2019] | The food additive, gamma-linolenic acid safflower oil, may be safely used in animal food as a source of gamma-linolenic acid and other omega-6 fatty acids in accordance with the following conditions: (a) The additive is the oil obtained from whole seeds and/or partially dehulled seeds of a Carthamus tinctorius L. safflower Centennial variety genetically engineered to express the delta-6-desaturase gene from Saprolegnia diclina Humphrey. The 453 amino acid, delta-6-desaturase enzyme converts the fatty acid linoleic acid to gamma-linolenic acid (all- cis -6,9,12-octadecatrienoic acid) during seed development. (1) The additive obtained from the seeds of the genetically engineered safflower Centennial variety may be blended with oil obtained from seeds of non-engineered oleic acid safflower varieties in order to meet the specifications required for the additive or the blend in paragraph (a)(2) of this section. (2) The additive or a safflower oil blend containing the additive for use in animal food meets the following specifications: (i) Crude fat content of the additive or the safflower oil blend is not less than 99.5 percent. (ii) Gamma-linolenic acid content is between 350 and 450 milligrams (mg) gamma-linolenic acid per gram of the additive or the safflower oil blend. (iii) Total content of stearidonic acid and cis, cis -6,9-octadecadienoic acid in the additive or the safflower oil blend must not exceed a total of 0.3 percent. (b) Addition of the additive, or the safflower oil blend, to complete dry adult maintenance dog food must meet the following: (1) Addition of the additive or the safflower oil blend cannot provide more than 36 mg gamma-linolenic acid per kilogram body weight of the dog per day in more than 86 mg of the additive or the safflower oil blend. This maximum addition rate of the additive, or the safflower oil blend, is 0.3 percent of a complete dry adult maintenance dog food containing 3,600 kilocalories of metabolizable energy per kilogram of food as-fed. (2) Adjustments must be made… | |||
| 21:21:6.0.1.1.23.2.2.31 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.496 Guanidinoacetic acid. | FDA | [81 FR 86269, Nov. 30, 2016, as amended at 86 FR 37038, July 14, 2021] | The food additive, guanidinoacetic acid, may be safely used in poultry feeds in accordance with the following prescribed conditions: (a) The additive is manufactured by reacting glycine with cyanamide in an aqueous solution. (b) The additive is used or intended for use at levels not to exceed 0.12 percent of the complete feed: (1) To spare arginine in broiler chicken and turkey feeds; or (2) As a precursor of creatine in poultry feeds. (c) The additive consists of not less than 97 percent guanidinoacetic acid [ N -(aminoiminomethyl)-glycine] (CAS 352-97-6) by weight. (d) The additive meets the following specifications: (1) Dicyandiamide not to exceed 0.5 percent; (2) Cyanamide not to exceed 0.01 percent; (3) Melamine not to exceed 15 parts per million (ppm); (4) Sum of ammeline, ammelide, and cyanuric acid not to exceed 35 ppm; and (5) Water not to exceed 1 percent. (e) To assure safe use of the additive in addition to the other information required by the Federal Food, Drug, and Cosmetic Act: (1) The label and labeling of the additive, any feed premix, and complete feed shall contain the name of the additive. (2) The label and labeling of the additive and any feed premix shall also contain: (i) A statement to indicate the maximum use level of guanidinoacetic acid must not exceed 0.12 percent of the complete feed for poultry; and (ii) Adequate directions for use. | |||
| 21:21:6.0.1.1.23.2.2.32 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.500 Condensed, extracted glutamic acid fermentation product. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 89 FR 33231, Apr. 29, 2024] | Condensed, extracted glutamic acid fermentation product may be safely used in animal feed under the following conditions: (a) The additive is a concentrated mixture of the liquor remaining from the extraction of glutamic acid, combined with the cells of Corynebacterium glutamicum used to produce the glutamic acid. (b) It is used or intended for use as follows: (1) In poultry feed as a source of protein in an amount not to exceed 5 percent of the total ration. (2) In cattle feed as a source of protein in an amount not to exceed 10 percent of the feed. (c) In order to assure safe use, the label and labeling of the additive shall bear, in addition to the other information required by the Act, the following: (1) The name of the additive. (2) A statement of the concentration of the additive contained in any mixture. (3) Adequate directions for use. | |||
| 21:21:6.0.1.1.23.2.2.33 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.520 Hemicellulose extract. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 43 FR 11181, Mar. 17, 1978] | Hemicellulose extract may be safely used in animal feed when incorporated therein in accordance with the following conditions: (a) The additive is produced from the aqueous extract obtained by the treatment of wood with water at elevated temperatures (325 degrees-535 degrees F) and pressure (80 to 900 pounds per square inch) and contains primarily pentose and hexose sugars. (b) The additive may be used in a liquid or dry state with the liquid product containing not less than 55 percent carbohydrate and the dry product containing not less than 84 percent carbohydrate. (c) The additive is used as a source of metabolizable energy in animal feed in accordance with good manufacturing and feeding practices. | |||
| 21:21:6.0.1.1.23.2.2.34 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.530 Hydrogenated corn syrup. | FDA | [45 FR 22920, Apr. 4, 1980] | (a) Identity. The product is produced by hydrogenation of corn syrup over a nickel catalyst. (b) Specifications. The product contains 70 percent hydrogenated corn syrup and a maximum of 0.5 percent reducing sugars. (c) Uses. The product is used as a humectant and plasticizer in preparation of soft-moist dog and cat foods. (d) Limitations. The product is preferably stored in a closed, stainless steel or aluminum container. The level of use of the product shall not exceed 15 percent of the total weight of the pet food formulation. (e) Labeling. The labeling shall bear, in addition to other information required by the Act: (1) The name of the additive. (2) Adequate directions for use in accordance with the provisions in paragraph (d) of this section. | |||
| 21:21:6.0.1.1.23.2.2.35 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.540 Hydrolyzed leather meal. | FDA | (a) Identity. Hydrolyzed leather meal is produced from leather scraps that are treated with steam for not less than 33 minutes at a pressure of not less than 125 pounds per square inch. (b) Specifications. The additive shall conform to the following percent-by-weight specifications: Moisture, not less than 5 percent nor more than 10 percent. Crude protein, not less than 60 percent. Crude fat, not less than 5 percent. Crude fiber, not more than 6 percent. Chromium, not more than 2.75 percent. Moisture, not less than 5 percent nor more than 10 percent. Crude protein, not less than 60 percent. Crude fat, not less than 5 percent. Crude fiber, not more than 6 percent. Chromium, not more than 2.75 percent. (c) Use. It is used or intended for use as a source of protein in swine feeds in an amount not to exceed 1.0 percent by weight of the finished feed. (d) Labeling. The labels and labeling shall bear, in addition to the other information required by the Act: (1) The name of the additive, hydrolyzed leather meal. (2) Adequate directions to provide finished feeds complying with paragraph (c) of this section. | ||||
| 21:21:6.0.1.1.23.2.2.36 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.550 25-hydroxyvitamin D | FDA | [83 FR 49486, Oct. 2, 2018] | The food additive, 25-hydroxyvitamin D 3 , may be safely used in accordance with the following prescribed conditions: (a) The additive is used or intended for use as a source of vitamin D 3 activity in animal feed or drinking water in accordance with good manufacturing and feeding practices as follows: (1) In feed or drinking water of layer and breeder chickens not to exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking water. (2) In feed or drinking water of turkeys not to exceed: (i) 92 ppb in feed; or (ii) In drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks of age. (b) The additive consists of not less than 94 percent 25-hydroxyvitamin D 3 (9,10-secocholesta-5,7,10(19)-triene-3β, 25-diol). (c) The additive meets the following specifications: (1) Not more than 1 percent of any individual sterol. (2) Not more than 5 percent water. (3) Not more than 20 parts per million (ppm) lead. (4) Not more than 20 ppm aluminum. (5) Not more than 1.0 percent solvents and non-detectable levels of 2′, 4′, 5′, 7′ tetraiodofluorescin. (6) Not more than 1 ppb 1, 25-dihydroxycholecalciferol. (d) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain: (1) The name of the additive. (2) A statement to indicate the maximum use level of 25-hydroxyvitamin D 3 must not exceed 69 ppb in feed or 34.5 ppb in drinking water for layer and breeder chickens. (3) A statement to indicate for turkeys the maximum use level of 25-hydroxyvitamin D 3 must not exceed 92 ppb in feed; or in drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks of age. (4) Adequate use directions to ensure that 25-hydroxyvitamin D 3 (and all premixes) is uniformly blended throughout the feed or drinking water. (5) An expiration date on all premix labeling. … | |||
| 21:21:6.0.1.1.23.2.2.37 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.560 Iron ammonium citrate. | FDA | Iron ammonium citrate may be safely used in animal feed in accordance with the following prescribed conditions: (a) The additive is the chemical green ferric ammonium citrate. (b) The additive is used or intended for use as an anticaking agent in salt for animal consumption so that the level of iron ammonium citrate does not exceed 25 parts per million (0.0025 percent) in the finished salt. (c) To assure safe use of the additive the label or labeling of the additive shall bear, in addition to the other information required by the Act: (1) The name of the additive. (2) Adequate directions to provide a final product that complies with the limitations prescribed in paragraph (b) of this section. | ||||
| 21:21:6.0.1.1.23.2.2.38 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.580 Iron-choline citrate complex. | FDA | Iron-choline citrate complex made by reacting approximately equimolecular quantities of ferric hydroxide, choline, and citric acid may be safely used as a source of iron in animal feed. | ||||
| 21:21:6.0.1.1.23.2.2.39 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.587 Komagataella pastoris dried yeast. | FDA | [58 FR 59170, Nov. 8, 1993. Redesignated and amended at 89 FR 72315, Sept. 5, 2024] | (a) Identity. The food additive Komagataella pastoris dried yeast is non-viable and may be used in feed formulations of broiler chickens as a source of protein not to exceed 10 percent by weight of the total formulation. (b) Specifications. The additive shall conform to the following percent-by-weight specifications: (1) Crude protein, not less than 60 percent. (2) Crude fat, not less than 2 percent. (3) Crude fiber, not more than 2 percent. (4) Ash, not more than 13 percent. (5) Moisture, not more than 6 percent. (c) Use. To ensure safe use, the labeling of the additive and any feed additive supplement, concentrate, or premix prepared therefrom shall bear, in addition to other required information, the name of the additive, directions for use to provide not more than 10 percent by weight of the total ration, and the statement “Caution: Not to be used in layers or other poultry intended for breeding.” | |||
| 21:21:6.0.1.1.23.2.2.4 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.160 Ammoniated rice hulls. | FDA | The food additive ammoniated rice hulls may be safely used in accordance with the following prescribed conditions: (a) The food additive is the product obtained by the treatment of ground rice hulls with monocalcium phosphate and anhydrous ammonia at a temperature of 350 °F and a pressure of 175 pounds per square inch. (b) It is used or intended for use in the feed of beef cattle as a source of crude fiber and as the sole source of nonprotein nitrogen in an amount not to exceed 20 percent of the total ration. (c) To assure safe use of the additive, the label and labeling of the additive and of any feed additive supplement, feed additive concentrate, or feed additive premix prepared therefrom, shall contain, in addition to other information required by the act, the following: (1) The name of the additive. (2) The maximum percentage of equivalent crude protein from the nonprotein nitrogen. (3) Directions for use to provide not more than 20 percent of the additive in the total ration, and a prominent statement: “Warning—This feed should be used only in accordance with the directions furnished on the label.” | ||||
| 21:21:6.0.1.1.23.2.2.40 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.600 Lignin sulfonates. | FDA | Lignin sulfonates may be safely used in animal feeds in accordance with the following prescribed conditions: (a) For the purpose of this section, the food additive is either one, or a combination of, the ammonium, calcium, magnesium, or sodium salts of the extract of spent sulfite liquor derived from the sulfite digestion of wood or of abaca ( Musa textilis ) or of sisal ( Agave sisalana ) in either a liquid form (moisture not to exceed 50 percent by weight) or dry form (moisture not to exceed 6 percent by weight). (b) It is used or intended for use in an amount calculated on a dry weight basis, as follows: (1) As a pelleting aid in the liquid or dry form in an amount not to exceed 4 percent of the finished pellets. (2) As a binding aid in the liquid form in the flaking of feed grains in an amount not to exceed 4 percent of the flaked grain. (3) As a surfactant in molasses used in feeds, as liquid lignin sulfonate, in an amount not to exceed 11 percent of the molasses. (4) As a source of metabolizable energy, in the liquid or dry form, in an amount not to exceed 4 percent of the finished feed. | ||||
| 21:21:6.0.1.1.23.2.2.41 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.615 Marine microalgae. | FDA | [83 FR 19935, May 7, 2018] | The food additive, marine microalgae, may be safely used as a source of docosahexaenoic acid (DHA) and other omega-3 fatty acids in accordance with the following prescribed conditions: (a) The additive is dried whole cells of nonviable, nontoxigenic, nonpathogenic Schizochytrium sp. algae grown as a pure culture. (b) The additive is used in complete, dry adult maintenance food for dogs in accordance with good manufacturing and feeding practices not to exceed 16.5 pounds per ton (7.5 kilograms (kg) per 1000 kg) of complete, dry, adult maintenance dog food. (c) The additive consists of not less than 17.0 percent (4 Z, 7 Z, 10 Z, 13 Z, 16 Z, 19 Z )-docosa-4,7,10,13,16,19-hexaenoic acid (docosahexaenoic acid or DHA). (d) The additive meets the following specifications: (1) Not less than 40 percent crude fat; (2) Not more than 12 percent ash; (3) Not more than 8 percent unsaponifiable matter; (4) Not more than 5 percent insoluble impurities; (5) Not more than 5 percent free fatty acids; and (6) Not more than 6 percent water. (e) To ensure the safe use of the additive, in addition to other information required by the Federal Food, Drug, and Cosmetic Act: (1) The label and labeling of the additive, any feed premix, and complete feed, shall contain the name of the additive, marine microalgae. (2) The label and labeling of the additive and any feed premix shall also contain: (i) A statement to indicate that the maximum use level of the additive shall not exceed 16.5 pounds per ton (7.5 kg per 1000 kg) of complete, dry, adult maintenance dog food. (ii) Adequate directions for use. | |||
| 21:21:6.0.1.1.23.2.2.42 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.620 Menadione dimethylpyrimidinol bisulfite. | FDA | The food additive, menadione dimethylpyrimidinol bisulfite, may be safely used in accordance with the following conditions: (a) The additive is the 2-hydroxy-4,6-dimethylpyrimidinol salt of menadione (C 1 7 H 1 8 O 6 N 2 S). (b) The additive is used or intended for use as a nutritional supplement for the prevention of vitamin K deficiency as follows: (1) In chicken and turkey feed at a level not to exceed 2 grams per ton of complete feed. (2) In the feed of growing and finishing swine at a level not to exceed 10 grams per ton of feed. (c) To assure safe use, the label and labeling of the additive shall bear adequate directions for use. | ||||
| 21:21:6.0.1.1.23.2.2.43 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.625 Menadione nicotinamide bisulfite. | FDA | [64 FR 46840, Aug. 27, 1999] | The food additive may be safely used as follows: (a) The additive is 1,2,3,4-tetrahydro-2-methyl-1,4-dioxo-2-naphthalene sulfonic acid with 3-pyridine carboxylic acid amine (CAS No. 73581-79-0). (b) The additive is used or intended for use as a nutritional supplement for both the prevention of vitamin K deficiency and as a source of supplemental niacin as follows: (1) In chicken and turkey feeds at a level not to exceed 2 grams per ton of complete feed. (2) In growing and finishing swine feeds at a level not to exceed 10 grams per ton of complete feed. (c) To assure safe use, the label and labeling of the additive shall bear adequate directions for use. | |||
| 21:21:6.0.1.1.23.2.2.44 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.637 Methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12-octadecadienoic acids). | FDA | [73 FR 64198, Oct. 29, 2008, as amended at 87 FR 21019, Apr. 11, 2022] | The food additive, methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12-octadecadienoic acids) may be safely used in swine feed and feed for early lactation dairy cows (less than 100 days in milk) in accordance with the prescribed conditions: (a) The food additive is manufactured by the reaction of refined sunflower oil with methanol to produce fatty acid methyl esters, which then undergo conjugation to yield methyl esters of octadecadienoic acid. The additive consists of not less than 28 percent methyl ester of cis-9, trans-11-octadecadienoic acid, and not less than 28 percent methyl ester of trans-10, cis-12-octadecadienoic acid with the sum of the other methyl esters of octadecadienoic acid not to exceed 4 percent. The additive shall contain not less than 35 percent of other fatty acid esters composed of oleic acid, palmitic acid, stearic acid, linoleic acid, and other associated acid esters. (b) The additive is used or intended for use in the feed of: (1) Growing and finishing swine as a source of fatty acids at levels not to exceed 0.6% in the finished feed. (2) Early lactation dairy cows to reduce the energy concentration in milk when fed at levels not to exceed 33 grams per cow per day. (c) The additive meets the following specifications: (1) Free methyl alcohol not to exceed 0.015%. (2) Insoluble impurities not to exceed 0.1%. (3) Moisture not to exceed 0.5%. (4) Unsaponifiable matter not to exceed 1.0%. (d) To assure safe use of the additive, in addition to the other information required by the act: (1) The label and labeling of the additive and any feed premix shall bear the following: (i) The name of the additive. (ii) A statement to indicate that methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) must not be added to vitamin or mineral premixes. (2) The label and labeling of the additive, any feed premix, or complete feed prepared therefrom shall bear adequate directions for use. | |||
| 21:21:6.0.1.1.23.2.2.45 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.640 Methyl esters of higher fatty acids. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 47 FR 9397, Mar. 5, 1982; 54 FR 18281, Apr. 28, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] | The food additive methyl esters of higher fatty acids may be safely used in animal feeds in accordance with the following prescribed conditions: (a) The food additive is manufactured by reaction of methyl alcohol with feed-grade fats or oils and consists of not less than 70 percent methyl esters of the following straight-chain monocarboxylic acids: Docosahexanoic acid, eicosapentanoic acid, linoleic acid, myristic acid, oleic acid, palmitic acid, palmitoleic acid, and stearic acid, and lesser amounts of the associated acid esters. (b) The food additive meets the following specifications: (1) Free methyl alcohol not to exceed 150 parts per million. (2) Unsaponifiable matter not to exceed 2 percent. (3) It is free of chick-edema factor or other factors toxic to chicks, as evidenced during the bioassay method for determining the chick-edema factor as prescribed in paragraph (b)(4)(ii) of this section. (4) For the purposes of this section: (i) Unsaponifiable matter shall be determined by the method described in Section 28.081, “Unsaponifiable Residue (20)—Official Final Action” of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed., 1980, p. 451, which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, 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. (ii) The chick-edema factor bioassay method described under “26. Oils, Fats, and Waxes” in the Journal of the Association of Official Agricultural Chemists, Vol. 44, Page 146 (1961), or the method described under “Chick-Edema Factor—Bioassay Method (34)—Official Final Action” in §§ 28.113-28.117, “Official Methods of Analysis of the Association of Official Analytical Chemists,” 12th Ed., 1975, pp. 509-511, which i… | |||
| 21:21:6.0.1.1.23.2.2.46 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.660 Methyl glucoside-coconut oil ester. | FDA | Methyl glucoside-coconut oil ester may be safely used in accordance with the following conditions: (a) The additive meets the specifications prescribed in § 172.816 of this chapter. (b) It is used as a surfactant in molasses intended for use in animal feed at a level not to exceed 320 parts per million. | ||||
| 21:21:6.0.1.1.23.2.2.47 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.680 Mineral oil. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 47 FR 41106, Sept. 17, 1982] | Mineral oil may be safely used in animal feed, subject to the provisions of this section. (a) Mineral oil, for the purpose of this section, is that complying with the definition and specifications contained in § 172.878 (a) and (b) or in § 178.3620(b)(1) (i) and (ii) of this chapter. (b) It is used in animal feeds for the following purposes: (1) To reduce dustiness of feeds or mineral supplements. (2) To serve as a lubricant in the preparation of pellets, cubes, or blocks and to improve resistance to moisture of such pellets, cubes, or blocks. (3) To prevent the segregation of trace minerals in mineralized salt. (4) To serve as a diluent carrier in the manufacture of feed grade biuret in accordance with good manufacturing practice. (5) For the removal of water from substances intended as ingredients of animal feed. (c) The quantity of mineral oil used in animal feed shall not exceed 3.0 percent in mineral supplements, nor shall it exceed 0.06 percent of the total ration when present in feed or feed concentrates. | |||
| 21:21:6.0.1.1.23.2.2.48 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.685 Natamycin. | FDA | [69 FR 19321, Apr. 13, 2004] | The food additive natamycin (CAS No. 7681-93-8) may be safely used in broiler chicken feeds in accordance with the following specifications: (a) The additive is a stereoisomer of 22-[(3-amino-3,6,dideoxy-β-D-mannopyranosyl)oxy]-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.0 5 , 7 ] octacosa-8,14,16,18,20-pentaene-25-carboxylic acid with the empirical formula C 33 H 47 NO 13 . (b) The additive shall conform to U.S.P. specifications. (c) The additive (as part of a premix composed of calcium carbonate, natamycin, and lactose) is used for retarding the growth of Aspergillus parasiticus in broiler chicken feeds for up to 14 days after the addition of natamycin. (d) Each pound (454 grams (g)) of the premix shall contain 434 (g) of calcium carbonate, 10 g of natamycin activity, and 10 g of lactose. The premix shall be mixed into broiler chicken feed at the rate of 1 pound (0.454 kilograms (kg)) per ton (908 kg) of feed to provide natamycin at a level of 11 parts per million (ppm). The premix shall be thoroughly mixed into the dry components of the broiler chicken feed before adding the liquid components. Broiler feeds to which the natamycin premix is added shall be used within 4 weeks of addition of the premix. (e) To assure the safe use of the additive, the label or labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, the following: (1) The name and CAS number of the additive, and its purpose. (2) A listing of ingredients consisting of calcium carbonate, the additive, and lactose and their proportions in the premix as prescribed under paragraph (d) of this section. (3) Adequate directions for use to ensure a broiler chicken feed that is in compliance with the limitations prescribed in paragraph (d) of this section. (4) An appropriate cautionary statement: “Caution: Store in a tightly-closed, light-resistant container in a cool, dry place.” (5) An expiration date of 1 year from the date of manufacture. (6) A contac… | |||
| 21:21:6.0.1.1.23.2.2.49 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.696 Feed grade sodium formate. | FDA | [81 FR 67154, Sept. 30, 2016, as amended at 81 FR 95027, Dec. 27, 2016] | The food additive, feed grade sodium formate, may be safely used in the manufacture of complete swine and poultry feeds in accordance with the following prescribed conditions: (a) The additive is manufactured by the reaction of 99 percent formic acid and 50 percent sodium hydroxide in water to produce a solution made up of at least 20.5 percent sodium salt of formic acid and not more than 61 percent formic acid. (b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed. (c) To assure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (d) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain: (1) The name of the additive. (2) Adequate directions for use, including a statement that feed grade sodium formate must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing feed grade sodium formate. (3) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (e) To assure safe use of the additive, in addition to the other information required by the act and paragraph (d) of this section, the label and labeling shall contain: (1) Appropriate warnings and safety precautions concerning feed grade sodium formate. (2) Statements identifying feed grade sodium formate as a corrosive and possible severe irritant. (3) Information about emergency aid in case of accidental exposure as follows: (i) Statements reflecting requirements of applicable sections of the Superfund Amendments… | |||
| 21:21:6.0.1.1.23.2.2.5 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.170 Ammonium formate. | FDA | [75 FR 41725, July 19, 2010, as amended at 78 FR 42692, July 17, 2013; 82 FR 52209, Nov. 13, 2017] | The food additive, ammonium formate, may be safely used in the manufacture of complete swine feeds in accordance with the following prescribed conditions: (a) The additive is manufactured by the reaction of 99.5 percent ammonia gas and 99 percent formic acid in a continuous loop reactor to produce a solution made up of 37 percent ammonium salt of formic acid and 62 percent formic acid. (b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine feeds at levels not to exceed 1.2 percent of the complete feed. (c) To ensure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (d) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act (the act), the label and labeling shall contain: (1) The name of the additive. (2) Adequate directions for use including a statement that ammonium formate must be uniformly applied and thoroughly mixed into complete swine feeds and that the complete swine feeds so treated shall be labeled as containing ammonium formate. (3) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (e) To ensure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act and paragraph (d) of this section, the label and labeling shall contain: (1) Appropriate warnings and safety precautions concerning ammonium formate (37 percent ammonium salt of formic acid and 62 percent formic acid). (2) Statements identifying ammonium formate in formic acid (37 percent ammonium salt of formic acid and 62 percent formic acid) as a corrosive and possible severe irritant. (3) Information about emergency aid i… | |||
| 21:21:6.0.1.1.23.2.2.50 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.700 Sodium nitrite. | FDA | Sodium nitrite may be safely used in canned pet food containing meat and fish in accordance with the following prescribed conditions: (a) It is used or intended for use alone as a preservative and color fixative in canned pet food containing fish, meat, and fish and meat byproducts so that the level of sodium nitrite does not exceed 20 parts per million. (b) To assure safe use of the additive, in addition to the other information required by the act: (1) The label of the additive shall bear: (i) The name of the additive. (ii) A statement of the concentration of the additive in any mixture. (2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (a) of this section. | ||||
| 21:21:6.0.1.1.23.2.2.51 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.720 Petrolatum. | FDA | Petrolatum may be safely used in or on animal feed, subject to the following prescribed conditions: (a) Petrolatum complies with the specifications set forth in the U.S. Pharmacopeia XVI for white petrolatum or in The National Formulary XII for yellow petrolatum. (b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b) of this chapter. Ultraviolet absorbance per centimeter path length: Ultraviolet absorbance per centimeter path length: (c) It is used in animal feed for the following purposes: (1) To reduce dustiness of feeds or mineral supplements. (2) To serve as a lubricant in the preparation of pellets, cubes, or blocks, and to improve resistance to moisture of such pellets, cubes, or blocks. (d) The quantity of petrolatum present in animal feeds from the uses specified in paragraph (c) of this section shall not exceed 3 percent in mineral supplements nor shall it exceed 0.06 percent of the total ration when present in feed or feed concentrates. (e) When used in combination with technical white mineral oil for the uses described in paragraph (c) of this section, the total quantity of combined petrolatum and technical white mineral oil shall not exceed the limits prescribed in paragraph (d) of this section. (f) Petrolatum may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the act, in an amount not greater than that required to produce its intended effect. | ||||
| 21:21:6.0.1.1.23.2.2.52 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.740 Odorless light petroleum hydrocarbons. | FDA | Odorless light petroleum hydrocarbons complying with § 172.884(a) and (b) of this chapter may be safely used in an amount not in excess of that required as a component of insecticide formulations used in compliance with regulations issued in this part. | ||||
| 21:21:6.0.1.1.23.2.2.53 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.760 Poloxalene. | FDA | The food additive poloxalene may be safely used in accordance with the following prescribed conditions: (a) The additive consists of polyoxy-propylene-polyoxyethylene glycol non-ionic block polymer meeting the following specifications: (1) Molecular weight range: 2,850-3,150. (2) Hydroxyl number: 35.7-39.4. (3) Cloud point (10 percent solution): 42 °C-46 °C. (4) Structural formula: (b) In feed as a surfactant for the flaking of feed grains when added to liquid grain conditioner in an amount not to exceed 1.0 percent of the conditioner. The conditioner is added to the feed at a rate of 1 quart per ton of feed. (c) The label and labeling shall bear, in addition to the other information required by the Act: (1) The name of the additive. (2) Adequate directions and warnings for use. | ||||
| 21:21:6.0.1.1.23.2.2.54 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.780 Polyethylene. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18282, Apr. 28, 1989] | (a) Identity. Polyethylene consists of basic polymers manufactured by the catalytic polymerization of ethylene. (b) Specifications. (1) For the purposes of this section, polyethylene shall meet the specifications in item 2.1 of § 177.1520(c) of this chapter. (2) The polyethylene is designed in a pellet form in a configuration presenting maximum angular surface having the following dimensions in centimeters: 0.9 ±0.1 × 0.8 ±0.1 × 1.2 ±0.1 0.9 ±0.1 × 0.8 ±0.1 × 1.2 ±0.1 (c) Use. It is used as a replacement for roughage in feedlot rations for finishing slaughter cattle. (d) Labeling. The labels and labeling shall bear in addition to the other information required by the Act: (1) The name of the additive “polyethylene roughage replacement.” (2) Adequate directions for use which shall provide for the administration of one-half pound of polyethylene pellets per head per day for 6 successive days. All natural roughage should be removed for a minimum of 12 hours prior to administration of polyethylene roughage replacement. Roughage replacement must be adequately mixed in the ration for uniform distribution. | |||
| 21:21:6.0.1.1.23.2.2.55 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.800 Polyethylene glycol (400) mono- and dioleate. | FDA | (a) The food additive polyethylene glycol (400) mono- and dioleate meets the following specifications: Saponification number, 80-88; acid number, 5.0 maximum; and average molecular weight range, 640-680. (b) It is used as a processing aid in the production of animal feeds when present as a result of its addition to molasses in an amount not to exceed 250 parts per million of the molasses. | ||||
| 21:21:6.0.1.1.23.2.2.56 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.820 Polyoxyethylene glycol (400) mono- and dioleates. | FDA | The food additive polyoxyethylene glycol (400) mono- and dioleates may be safely used as an emulsifier in calf-milk replacer formulations. | ||||
| 21:21:6.0.1.1.23.2.2.57 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.840 Polysorbate 60. | FDA | The food additive polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) may be safely used in animal feeds in accordance with the following prescribed conditions: (a) It is used alone or in combination with sorbitan monostearate as an emulsifier in mineral premixes and dietary supplements for animal feeds. (b) It is used as an emulsifier in milk-replacer formulations for calves. | ||||
| 21:21:6.0.1.1.23.2.2.58 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.860 Polysorbate 80. | FDA | The food additive polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) may be safely used as an emulsifier in milk-replacer formulations for calves. | ||||
| 21:21:6.0.1.1.23.2.2.59 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.870 Poly(2-vinylpyridine-co-styrene). | FDA | [57 FR 7875, Mar. 5, 1992, as amended at 57 FR 24187, June 8, 1992; 61 FR 11547, Mar. 21, 1996; 70 FR 13100, Mar. 18, 2005] | The food additive poly(2-vinylpyridine-co-styrene) may be safely used as nutrient protectant in feed for beef cattle and dairy cattle and replacement dairy heifers when used in accordance with the following conditions: (a) The additive meets the following specifications: 1 Inherent viscosity of a 0.25 percent (weight/volume) solution in dimethylformamide. (b) The additive is used in the manufacture of rumen-stable, abomasum-dispersible nutrient(s) for beef cattle and dairy cattle and replacement dairy heifers such that the maximum use of the additive from all sources does not exceed 5.1 grams per head per day. The additive may be used to protect the following nutrients: (1) Methionine. The resulting product must contain a maximum of 10 percent poly(2-vinylpyridine-co-styrene) by weight and a minimum of 55 percent methionine by weight. The coated methionine must be established through in vitro tests to be at least 90 percent rumen-stable, of which at least 90 percent is subsequently dispersible under abomasal conditions. (2) Methionine and lysine. The resulting product must contain a maximum of 10 percent poly(2-vinylpyridine-co-styrene) by weight and a minimum of a combined total of 55 percent methionine and lysine by weight. The coated methionine and lysine must be established through in vitro tests to be at least 90 percent rumen-stable, of which at least 90 percent is subsequently dispersible under abomasal conditions. (c) Label and labeling. To ensure safe use of the additive, the label and labeling of the additive and of any feed additive supplement, feed additive concentrate, feed additive premix, or liquid feed supplement prepared therefrom, shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the following: (1) The name of the additive. (2) A statement of the concentration of poly(2-vinylpyridine-co-styrene) in any product or mixture. (3) Adequate directions for the use of the rumen-stable, abomasum-dispersible nutrient(s) products. (4) Th… | |||
| 21:21:6.0.1.1.23.2.2.6 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.180 Anhydrous ammonia. | FDA | [44 FR 40284, July 10, 1979] | (a) The food additive anhydrous ammonia is applied directly to corn plant material and thoroughly blended prior to ensiling. It is used or intended for use as a source of nonprotein nitrogen in cattle feed in accordance with paragraphs (a)(1), (2), or (3) as follows: (1)(i) The food additive anhydrous ammonia is applied as a component of an aqueous premix containing 16 to 17 percent ammonia, with molasses, minerals, and not less than 83 percent crude protein. The premix is a source of nonprotein nitrogen and minerals. (ii) In addition to the requirements of paragraph (b) of this section, the labeling shall bear an expiration date of not more than 10 weeks after date of manufacture; a statement that additional protein should not be fed to lactating dairy cows producing less than 32 pounds of milk per day nor beef cattle consuming less than 1 percent of body weight daily in shelled corn; and a warning not to use additional trace mineral supplementation with treated silage. (2)(i) The food additive anhydrous ammonia is applied directly to corn plant material for use in dairy or beef cattle rations. (ii) The anhydrous ammonia is applied at a rate not to exceed the equivalent of 0.35 percent of the corn plant material. (iii) It is applied to corn plant material containing 30 to 35 percent dry matter. (iv) It is applied so that 75 to 85 percent of the additive is liquid at ambient pressure. (3)(i) The food additive anhydrous ammonia is applied after being diluted to a 15 to 30 percent aqueous ammonia solution (by weight). (ii) The anhydrous ammonia solution is applied at a rate not to exceed anhydrous ammonia equivalent to 0.3 percent of the corn plant material. (iii) It is applied to corn plant material containing 28 to 38 percent dry matter. (iv) The silage treated with aqueous ammonia is to be fed to dairy cattle only. (b) Its labeling shall bear, in addition to the other requirements of the act, the name of the additive, the concentration of ammonia, the maximum percentage of equivalent crude protein fro… | |||
| 21:21:6.0.1.1.23.2.2.60 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.880 Normal propyl alcohol. | FDA | Normal propyl alcohol may be safely used in feeds and feed supplements for cattle as a source of metabolizable energy. It is incorporated in the feed or feed supplement in an amount which provides not more than 54.5 grams of the additive per head per day. | ||||
| 21:21:6.0.1.1.23.2.2.61 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.900 Pyrophyllite. | FDA | Pyrophyllite (aluminum silicate monohydrate) may be safely used as the sole anticaking aid, blending agent, pelleting aid, or carrier in animal feed when incorporated therein in an amount not to exceed 2 percent in complete animal feed. | ||||
| 21:21:6.0.1.1.23.2.2.62 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.914 Salts of volatile fatty acids. | FDA | [49 FR 45125, Nov. 15, 1984; 50 FR 8606, Mar. 4, 1985, as amended at 70 FR 13100, Mar. 18, 2005] | (a) Identity. The food additive is a blend containing the ammonium or calcium salt of isobutyric acid and the ammonium or calcium salts of a mixture of 5-carbon acids—isovaleric, 2-methylbutyric, and n -valeric. (b) Specifications. The additive contains ammonium or calcium salts of volatile fatty acids and shall conform to the following specifications: (1) Ammonium salts: (2) Calcium salts: (c) Use. The additive is used or intended for use as a source of energy in dairy cattle feed. (d) Labeling. The label and labeling of the additive in any feed, feed supplement, feed concentrate, feed premix, or liquid feed supplement prepared therefrom shall bear, in addition to other information required by the act, the following: (1) The name of the additive. (2) Adequate directions for use, including statements expressing maximum use levels. For ammonium salts of volatile fatty acids, the statements: “Not to exceed 160 grams per head per day thoroughly mixed in dairy cattle feed as a source of energy.” For calcium salts of volatile fatty acids, the statement: “Not to exceed 135 grams per head per day thoroughly mixed in dairy cattle feed as a source of energy.” | |||
| 21:21:6.0.1.1.23.2.2.63 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.920 Selenium. | FDA | [52 FR 10888, Apr. 6, 1987; 52 FR 21001, June 4, 1987, as amended at 54 FR 14215, Apr. 10, 1989; 54 FR 15874, Apr. 19, 1989; 60 FR 53703, Oct. 17, 1995; 65 FR 35824, June 6, 2000; 65 FR 53167, Sept. 1, 2000; 67 FR 46851, July 17, 2002; 68 FR 52340, Sept. 3, 2003; 72 FR 39561, July 19, 2007; 84 FR 7993, Mar. 6, 2019; 86 FR 37036, July 14, 2021; 90 FR 21220, May 19, 2025] | (a) Public Law 103-354 enacted October 13, 1994 (the 1994 Act), states that FDA shall not implement or enforce the final rule issued on September 13, 1993 (58 FR 47962), in which FDA stayed the 1987 amendments and any modification of such rule issued after enactment of the 1994 Act; unless the Commissioner of Food and Drugs makes a determination that: (1) Selenium additives are not essential at levels authorized in the absence of such final rule, to maintain animal nutrition and protect animal health; (2) selenium at such levels is not safe to the animals consuming the additive; (3) selenium at such levels is not safe to individuals consuming edible portions of animals that receive the additive; (4) selenium at such levels does not achieve its intended effect of promoting normal growth and reproduction of livestock and poultry; and (5) the manufacture and use of selenium at such levels cannot reasonably be controlled by adherence to current good manufacturing practice requirements. (6) Paragraphs (b) through (i) of this section provide the currently acceptable levels of selenium supplementation. (b) The food additive selenium is a nutrient administered in animal feed as sodium selenite or sodium selenate as provided in paragraph (c) of this section, as a controlled-release sodium selenite bolus as provided in paragraph (f) of this section, as selenium yeast as provided in paragraph (g) of this section, as selenomethionine hydroxy analogue as provided in paragraph (h) of this section, or as zinc-L-selenomethionine complex as provided in paragraph (i) of this section. (c) Selenium, as sodium selenite or sodium selenate, is added to feed as follows: (1) In complete feed for chickens, swine, turkeys, sheep, cattle, and ducks at a level not to exceed 0.3 part per million. (2) In feed supplements for limit feeding as follows: (i) Sheep: At a level not to exceed an intake of 0.7 milligram per head per day. (ii) Beef cattle: At a level not to exceed an intake of 3 milligrams per head per day. (3) In salt… | |||
| 21:21:6.0.1.1.23.2.2.64 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.940 Silicon dioxide. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 83 FR 8930, Mar. 2, 2018; 84 FR 7993, Mar. 6, 2019; 85 FR 33539, June 2, 2020] | The food additive silicon dioxide may be safely used in animal feed in accordance with the following conditions: (a) The food additive is manufactured by vapor phase hydrolysis or by other means whereby the particle size is such as to accomplish the intended effect. (b) It is used or intended for use as an anticaking agent, antifoaming agent, carrier, and/or grinding aid in animal feed, including ingredients, intermediate premixes, premixes, supplements, concentrates, and complete feed. (c) To ensure safe use of the additive, silicon dioxide is to be used in an amount not to exceed that reasonably required to accomplish its intended effect, and silicon dioxide from all sources cannot exceed 2 percent by weight of the complete feed. (d) To ensure safe use of the additive, the label and labeling of the additive and ingredients, intermediate premixes, premixes, supplements, concentrates, and complete feed containing the additive shall meet the requirements of the Federal Food, Drug, and Cosmetic Act, including part 501 of this chapter. (e) To ensure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling of the additive and ingredients, intermediate premixes, premixes, supplements, and concentrates containing the additive shall have: (1) A statement of the concentration of the additive. (2) A statement that silicon dioxide from all sources cannot exceed 2 percent by weight of the complete feed. | |||
| 21:21:6.0.1.1.23.2.2.65 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.960 Sorbitan monostearate. | FDA | The food additive sorbitan monostearate may be safely used alone or in combination with polysorbate 60 as an emulsifier in mineral premixes and dietary supplements for animal feeds. | ||||
| 21:21:6.0.1.1.23.2.2.66 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.980 Taurine. | FDA | The food additive taurine (2-amino-ethanesulfonic acid) may be safely used in feed in accordance with the following prescribed conditions: (a) It is used as a nutritional supplement in the feed of growing chickens. (b) It is added to complete feeds so that the total taurine content does not exceed 0.054 percent of the feed. (c) To assure safe use of the additive, the label and labeling shall bear in addition to the other information required by the Act: (1) The name of the additive. (2) The quantity of the additive contained therein. (3) Adequate directions for use. | ||||
| 21:21:6.0.1.1.23.2.2.67 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.1000 Verxite. | FDA | The food additive verxite may be safely used in animal feed in accordance with the following prescribed conditions: (a) The additive is a magnesium-aluminum-iron silicate conforming to one of the following: (1)(i) Verxite granules: The additive contains a minimum of 98 percent of hydrobiotite; it is thermally expanded and has a bulk density of from 5 to 9 pounds per cubic foot. (ii) It is used or intended for use: ( a ) In poultry feed at a level not to exceed 5 percent of the weight of the finished feed as a nonnutritive bulking agent for restricting calorie intake in pullet replacement feeds. ( b ) As an anticaking or blending agent, pelleting aid, or nonnutritive carrier for the incorporation of nutrients in poultry, swine, dog, or ruminant feeds, in an amount not to exceed that necessary to accomplish its intended effect and in no case to exceed 1.5 percent of the dog feed or 5 percent of the final feed for other animals. (2)(i) Verxite flakes: The additive contains a minimum of 98 percent of hydrobiotite; it has a bulk density of from 20 to 30 pounds per cubic foot. (ii) It is used or intended for use as an anticaking or blending agent in ruminant feeds in an amount not to exceed that necessary to accomplish its intended effect and in no case to exceed 1 percent by weight of the final feed for ruminants. (3)(i) Verxite grits: The additive contains a minimum of 80 percent of hydrobiotite; it has a bulk density of from 40 to 50 pounds per cubic foot. (ii) It is used or intended for use as a partial roughage replacement in ruminant feeds in an amount not to exceed that necessary to accomplish its intended effect and in no case to exceed 1 percent by weight of the final feed. (b) To assure safe use of the additive, the label of any feed additive supplement, feed additive concentrate, feed additive premix, or complete feed prepared therefrom shall bear, in addition to the other information required by the Act, the name of the additive (verxite granules, verxite flakes, or verxite grits), adequate direct… | ||||
| 21:21:6.0.1.1.23.2.2.68 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.1010 Xanthan gum. | FDA | [49 FR 44630, Nov. 8, 1984] | The food additive xanthan gum may be safely used in animal feed as follows: (a) The food additive is xanthan gum as defined in § 172.695 of this chapter and meets all of the specifications thereof. (b) It is used or intended for use as a stabilizer, emulsifier, thickener, suspending agent, or bodying agent in animal feed as follows: (1) In calf milk replacers at a maximum use level of 0.1 percent, as fed. (2) In liquid feed supplements for ruminant animals at a maximum use level of 0.25 percent (5 pounds per ton). (c) To assure safe use of the additive: (1) The label of its container shall bear, in addition to other information required by the act, the name of the additive. (2) The label or labeling of the additive container shall bear adequate directions for use. | |||
| 21:21:6.0.1.1.23.2.2.69 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.1020 Yellow prussiate of soda. | FDA | [41 FR 38657, Sept. 10, 1976; 41 FR 48100, Nov. 2, 1976] | Yellow prussiate of soda (sodium ferrocyanide decahydrate: Na 4 Fe(Cn) 6 °-10H 2 O) may be safely used as an anticaking agent in salt for animal consumption at a level not to exceed 13 parts per million. The additive contains a minimum of 99.0 percent by weight of sodium ferrocyanide decahydrate. | |||
| 21:21:6.0.1.1.23.2.2.7 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.200 Condensed animal protein hydrolysate. | FDA | (a) Identity. The condensed animal protein hydrolysate is produced from the meat byproducts scraped from cured (salted) hides taken from cattle slaughtered for food consumption. The meat byproduct is hydrolyzed with heat and phosphoric acid. (b) Specifications. The additive shall conform to the following percent-by-weight specifications: Moisture, not less than 45 percent nor more than 50 percent. Protein, not less than 24 percent. Salt (NaCl), not more than 15 percent. Phosphorus, not less than 2.25 percent. Moisture, not less than 45 percent nor more than 50 percent. Protein, not less than 24 percent. Salt (NaCl), not more than 15 percent. Phosphorus, not less than 2.25 percent. (c) Uses. It is used or intended for use as a source of animal protein, phosphorus, and salt (NaCl) as follows: (1) In poultry and swine feed in an amount not to exceed 5 percent by weight of the feed. (2) In feed concentrates for cattle in an amount not to exceed 10 percent by weight of the concentrate. (d) Labeling. The label and labeling shall bear, in addition to the other information required by the act: (1) The name of the additive, condensed animal protein hydrolysate. (2) Adequate directions for use including maximum quantities permitted for each species and a guaranteed analysis of the additive. | ||||
| 21:21:6.0.1.1.23.2.2.8 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.210 Benzoic acid. | FDA | [79 FR 14176, Mar. 13, 2014] | The food additive, benzoic acid, may be safely used in the manufacture of complete swine feeds in accordance with the following prescribed conditions: (a) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine feeds at levels not to exceed 0.5 percent of the complete feed. (b) The additive consists of not less than 99.5 percent benzoic acid (CAS 65-85-0) by weight with the sum of 2-methylbiphenyl, 3-methylbiphenyl, 4-methylbiphenyl, benzyl benzoate, and isomers of dimethylbiphenyl not to exceed 0.01 percent by weight. (c) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act and paragraph (b) of this section, the label and labeling shall contain: (1) The name of the additive. (2) Adequate directions for use including a statement that benzoic acid must be uniformly applied and thoroughly mixed into complete swine feeds and that the complete swine feeds so treated shall be labeled as containing benzoic acid. (3) Appropriate warnings and safety precautions concerning benzoic acid. (4) A warning statement identifying benzoic acid as a possible irritant. (5) Information about emergency aid in case of accidental exposure. (6) Contact address and telephone number for reporting adverse reactions or to request a copy of the Material Safety Data Sheet (MSDS). | |||
| 21:21:6.0.1.1.23.2.2.9 | 21 | Food and Drugs | I | E | 573 | PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS | B | Subpart B—Food Additive Listing | § 573.220 Feed-grade biuret. | FDA | [41 FR 38652, Sept. 10, 1976, as amended at 68 FR 27904, May 22, 2003] | The food additive feed grade biuret may be safely used in ruminant feed in accordance with the following prescribed conditions: (a) The food additive is the product resulting from the controlled pyrolysis of urea conforming to the following specifications: (b) It is used in ruminant feeds as a source of nonprotein nitrogen. (c) To assure safe use of the additive: (1) The label and labeling of the additive and that of any feed additive supplement, feed additive concentrate, feed additive premix, or complete feed prepared therefrom shall contain, in addition to other information required by the act, the following: (i) The name of the additive. (ii) The maximum percentage of equivalent crude protein from nonprotein nitrogen. (2) The label shall recommend that the diet be balanced to provide adequate nutrients when equivalent crude protein from all forms of nonprotein nitrogen exceed one-third of the total crude protein in the total daily ration. | |||
| 24:24:3.1.1.3.4.0.1.1 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.1 Authority and purpose. | HUD | Section 4 of the Church Arson Prevention Act of 1996 (Pub. L. 104-155, approved July 3, 1996) authorizes HUD to guarantee loans made by financial institutions to certain nonprofit organizations to finance activities designed to remedy the damage and destruction to real and personal property caused by acts of arson or terrorism. This part establishes the general procedures and requirements that apply to HUD's guarantee of these loans. | ||||||
| 24:24:3.1.1.3.4.0.1.10 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.10 Fees for guaranteed loans. | HUD | (a) No fees will be assessed by HUD for its guaranty of a loan under this part. (b) The lender may assess the Borrower loan origination fees or other charges provided that such fees and charges are those charged by the lender to its other customers for similar transactions, and are no higher than those charged by the lender for similar transactions. | ||||||
| 24:24:3.1.1.3.4.0.1.11 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.11 Record access and recordkeeping. | HUD | Records pertaining to the loans made by the Financial Institution shall be held for the life of the loan. A lender with a Section 4 Guaranteed Loan shall allow HUD, the Comptroller General of the United States, and their authorized representatives access from time to time to any documents, papers or files which are pertinent to the guaranteed loan, and to inspect and make copies of such records which relate to any Section 4 Loan. Any inspection will be made during the lender's regular business hours or any other mutually convenient time. | ||||||
| 24:24:3.1.1.3.4.0.1.2 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.2 Definitions. | HUD | The following definitions are only applicable to loan guarantees under this part, and are not criminal definitions. Act means “The Church Arson Prevention Act of 1996” (Pub. L. 104-155, approved July 3, 1996). Arson means a fire or explosion causing damage to (or destruction of) real or personal property that a Qualified Certification Official determines, or reasonably believes, to be deliberately set. Borrower means an organization described in section 501(c)(3) of the Internal Revenue Code of 1986, as amended, whose property has been damaged or destroyed as a result of an act of arson or terrorism and that incurs a debt obligation to a financial institution for the purpose of carrying out activities eligible under his part. Financial Institution means a lender which may be a bank, trust company, savings and loan association, credit union, mortgage company, or other issuer regulated by the Federal Deposit Insurance Corporation, the Office of Thrift Supervision, the Credit Union Administration, or the U.S. Comptroller of the Currency. A Financial Institution may also be a Pension Fund. Guarantee means an obligation of the United States Government guaranteeing payment of the outstanding principal loan amount, in whole or in part, plus interest thereon, on a debt obligation of the Borrower to a Financial Institution upon failure of the Borrower to repay the debt. Guaranteed Loan Funds means funds received by the borrower from the Financial Institution to finance eligible activities under this part, the repayment of which is guaranteed by HUD. Loan Guarantee Agreement means an agreement between a Financial Institution and the Secretary detailing the rights, responsibilities, procedures, terms, and conditions under which a loan provided by a Financial Institution to a Borrower may be guaranteed under section 4 of the Act. Qualified Certification Official (QCO) —(1) For the purpose of certifying an act of arson. A State or local official authorized to investigate possible acts of arson. For the purpos… | ||||||
| 24:24:3.1.1.3.4.0.1.3 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.3 Eligible activities. | HUD | [61 FR 47405, Sept. 6, 1996, as amended at 62 FR 24574, May 6, 1997] | Guaranteed Loan Funds may be used by a Borrower for the following activities when it is certified in accordance with § 573.6(e) that the activity is necessary to address damage caused by an act or acts of arson or terrorism as certified in accordance with § 573.6(f): (a) Acquisition of improved or unimproved real property in fee or under long term lease. (b) Acquisition and installation of personal property. (c) Rehabilitation of real property owner, acquired, or leased by the Borrower. (d) Construction, reconstruction, or replacement of real property improvement. (e) Clearance, demolition, and removal, including movement of structures to other sites, of buildings, fixtures and improvements on real property. (f) Site preparation, including construction, reconstruction, or installation of site improvements, utilities, or facilities, which is related to the activities described in paragraph (a), (c), or (d) of this section. (g) Architectural, engineering, and similar services necessary to develop plans in connection with activities financed under paragraph (a), (b), (c), or (d) of this section. (h) Acquisition, installation and restoration of security systems. (i) Loans for refinancing existing indebtedness secured by a property which has been or will be acquired, constructed, rehabilitated or reconstructed, if such financing is determined to be appropriate to achieve the objectives of the Act and this part. (j) Other necessary project costs such as insurance, bonding, legal fees, appraisals, surveys, relocation, closing costs, etc., paid or incurred by the Borrower in connection with the completion of the above activities. | |||||
| 24:24:3.1.1.3.4.0.1.4 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.4 Loan term. | HUD | The term of the loan to be guaranteed by HUD under this part may not exceed 20 years. | ||||||
| 24:24:3.1.1.3.4.0.1.5 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.5 Underwriting standards and availability of loan guarantee assistance. | HUD | (a) HUD may, in its discretion, accept the underwriting standards of the Financial Institution making a loan to a Borrower. (b) HUD will not make the loan guarantee unless it determines that the guaranteed loan is an acceptable financial risk under HUD's generally applicable loan underwriting standards based on the following: (1) The Borrower's ability to pay debt service; and (2) The value of the collateral assigned or pledged as security for the repayment of the loan. (c) The provision of a loan guarantee to a Financial Institution and the amount of the guarantee do not depend in any way on the purpose, function, or identity of the organization to which the Financial Institution has made, or intends to make, a Section 4 Guaranteed Loan. (d) HUD may disapprove a request for loan guarantee assistance based on the availability of funding. (e) HUD may decline any Financial Institution's participation if its underwriting criteria are insufficient to make the guarantee an acceptable financial risk, or if the proposed interest rates or fees are unacceptable. HUD expects the proposed interest rates to take into account the value of the Federal guarantee. (f) HUD may limit the availability of Guaranteed Loan Funds to geographic areas having the greatest need, as determined by a needs analysis of the most current available date conducted by HUD. (g) Other requirements associated with the underwriting standards and guidelines shall be contained in the Loan Guarantee Agreement. | ||||||
| 24:24:3.1.1.3.4.0.1.6 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.6 Submission requirements. | HUD | A Financial Institution seeking a Section 4 Guaranteed Loan must submit to HUD the following documentation: (a) A statement that the institution is a Financial Institution as defined at § 573.2. (b) A statement that the Borrower is eligible as defined at § 573.2. (c) A description of each eligible activity for which the loan is requested. (d) A statement of other available funds to be used to finance the eligible activities (e.g., insurance proceeds). (e) A certification by the Borrower that the activities to be assisted resulted from an act of arson or terrorism which is the subject of the certification described in paragraph (f) of this section. (f) A certification by a QCO that the damage or destruction to be remedied by the use of the Guaranteed Loan Funds resulted from an act of arson or terrorism. (g) The environmental documentation required by § 573.8. (h) A narrative of the institution's underwriting standards used in reviewing the Borrower's loan request. (i) The interest rate on the loan and fees the lender intends to use in connection with the loan; and (j) The percentage of the loan for which a guarantee is requested. | ||||||
| 24:24:3.1.1.3.4.0.1.7 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.7 Loan guarantee agreement. | HUD | (a) The rights and responsibilities with respect to the guaranteed loan shall be substantially described in an agreement entered into between the Financial Institution, as the lender, and the Secretary, as the guarantor, which agreement shall provide that: (1) The lender has submitted or will submit a request for loan guarantee assistance that is accompanied by the Borrower's request for a loan to carry out eligible activities described in § 573.3; (2) The lender will require the Borrower to execute a promissory note promising to repay the guaranteed loan in accordance with the terms thereof; (3) The lender will require the Borrower to provide collateral security, to an extent and in a form, acceptable to HUD; (4) HUD reserves the right to limit loan guarantees to loans financing the replacement of damaged property with comparable new property; (5) The lender will follow certain claim procedures to be specified by HUD in connection with any defaults, including appropriate notification of default as required by HUD; (6) The lender will follow procedures for payment under the guarantee whereby the lender will be paid (up to the amount of guarantee) the amount owed to the lender less any amount recovered from the underlying collateral security for the loan; and (7) The lender will act as the fiscal agent for the loan, servicing the guaranteed loan, maintaining loan documents, and receiving the Borrower's payments of principal and interest. The Borrower and the lender may be required to execute a fiscal agency agreement. (b) In addition, the agreement shall contain other requirements, terms, and conditions required or approved by HUD. | ||||||
| 24:24:3.1.1.3.4.0.1.8 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.8 Environmental procedures and standards. | HUD | The environmental review requirements at 24 CFR part 50 are applicable to this part. (a) Environmental procedures. Before any lender's submission requesting a loan guarantee for the acquisition, rehabilitation, or construction of real property can be selected for a loan guarantee, HUD shall determine whether any environmental thresholds are exceeded in accordance with 24 CFR part 50, which implements the National Environmental Policy Act (NEPA) and the related Federal environmental laws and authorities listed under 24 CFR 50.4. To assist in complying with environmental requirements, Borrowers are encouraged to select sites that are free of environmental hazards and are to provide HUD with environmental data needed to make a determination of compliance. For successful Borrowers, the costs for preparing the environmental data are eligible as project costs. (1) If HUD determines that one or more of the thresholds are exceeded, HUD shall conduct a compliance review of the issue and, if appropriate, establish mitigating measures that the applicant shall carry out for the property. (2) The lender's submissions under § 573.6 shall provide HUD with: (i) Documentation for environmental threshold review; and (ii) Any previously issued environmental reviews prepared by local, State, or other Federal agencies for the proposed property. (3) In providing the above information, the Borrower is encouraged to contact the local community development agency to obtain any previously issued environmental reviews for the proposed property as well as for other relevant information that can be used in the applicant documentation for the environmental threshold review. (4) HUD reserves the right to disqualify any request where one or more environmental thresholds are exceeded if HUD determines that the compliance review cannot be satisfactorily completed. (5) If Guaranteed Loan Funds are requested for acquisition, rehabilitation, or construction, Borrowers and Financial Institutions are prohibited from committing or expending S… | ||||||
| 24:24:3.1.1.3.4.0.1.9 | 24 | Housing and Urban Development | V | C | 573 | PART 573—LOAN GUARANTEE RECOVERY FUND | § 573.9 Other requirements. | HUD | [61 FR 47405, Sept. 6, 1996, as amended at 64 FR 50226, Sept. 15, 1999; 80 FR 75938, Dec. 7, 2015] | (a) Nondiscrimination and equal opportunity. The nondiscrimination and equal opportunity requirements described in 24 CFR part 5, subpart A apply to this part. (b) 2 CFR part 200. The provisions of 2 CFR part 200 apply to guaranteed loans under this part. (c) Lead-based paint. Housing assisted under this part is subject to the lead-based paint requirements described in part 35, subparts A, B, E, G, and R of this title. (d) Labor standards —(1) Davis-Bacon. All laborers and mechanics employed by contractors or subcontractors in the performance of construction work financed in whole or in part with Guaranteed Loan Funds under this part shall be paid wages at rates not less than those prevailing on similar construction in the locality as determined by the Secretary of Labor in accordance with the Davis-Bacon Act, as amended (40 U.S.C. 276a-276a-5). This paragraph shall apply to the rehabilitation of residential property only if such property contains not less than 8 units. (2) Volunteers. The provisions of paragraph (d)(1) of this section shall not apply to volunteers under the conditions set forth in 24 CFR part 70. In applying part 70, loan guarantees under this part shall be treated as a program for which there is a statutory exemption for volunteers. (3) Labor standards. Any contract, subcontract, or building loan agreement executed for a project subject to Davis-Bacon wage rates under paragraph (d)(1) of this section shall comply with all labor standards and provisions of 29 CFR parts 1, 3 and 5 that would be applicable to a loan guarantee program to which Davis-Bacon wage rates are made applicable by statute. | |||||
| 49:49:7.1.1.1.2.0.1.1 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.1 Scope. | NHTSA | [69 FR 34959, June 23, 2004] | This part: (a) Sets forth the responsibilities under 49 U.S.C. 30116-30121 of manufacturers of motor vehicles and motor vehicle equipment with respect to safety-related defects and noncompliances with Federal motor vehicle safety standards in motor vehicles and items of motor vehicle equipment; and (b) Specifies requirements for— (1) Manufacturers to maintain lists of owners, purchasers, dealers, and distributors notified of defective and noncomplying motor vehicles and motor vehicle original and replacement equipment, (2) Reporting to the National Highway Traffic Safety Administration (NHTSA) defects in motor vehicles and motor vehicle equipment and noncompliances with motor vehicle safety standards prescribed under part 571 of this chapter, and (3) Providing quarterly reports on defect and noncompliance notification campaigns. | ||||||
| 49:49:7.1.1.1.2.0.1.10 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.10 Reporting the sale or lease of defective or noncompliant tires. | NHTSA | [65 FR 81413, Dec. 26, 2000, as amended at 72 FR 32016, June 11, 2007] | (a) Reporting requirement. Subject to paragraph (b) of this section, any person who knowingly and willfully sells or leases for use on a motor vehicle a defective tire or a tire that is not compliant with an applicable tire safety standard with actual knowledge that the manufacturer of such tire has notified its dealers of such defect or noncompliance as required under 49 U.S.C. 30118(c) or as required by an order under 49 U.S.C. 30118(b) must report that sale or lease to the Associate Administrator for Enforcement, NHTSA, 1200 New Jersey Ave., SE., Washington, DC 20590. (b) Exclusions from reporting requirement. Paragraph (a) of this section is not applicable where, before delivery under a sale or lease of a tire: (1) The defect or noncompliance of the tire is remedied as required under 49 U.S.C. 30120; or (2) Notification of the defect or noncompliance is required by an order under 49 U.S.C. 30118(b), but enforcement of the order is restrained or the order is set aside in a civil action to which 49 U.S.C. 30121(d) applies. (c) Contents of report; requirement of signature. (1) A report submitted pursuant to paragraph (a) of this section must contain the following information, where that information is available to the person selling or leasing the defective or noncompliant tire: (i) A statement that the report is being submitted pursuant to 49 CFR 573.10(a) (sale or lease of defective or noncompliant tires); (ii) The name, address and phone number of the person who purchased or leased the tire; (iii) The name of the manufacturer of the tire; (iv) The tire's brand name, model name, and size; (v) The tire's DOT identification number; (vi) The date of the sale or lease; and (vii) The name, address, and telephone number of the seller or lessor. (2) Each report must be dated and signed, with the name of the person signing the report legibly printed or typed below the signature. (d) Reports required to be submitted pursuant to this section must be submitted no more than that five working days after … | ||||||
| 49:49:7.1.1.1.2.0.1.11 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.11 Prohibition on sale or lease of new defective and noncompliant motor vehicles and items of replacement equipment. | NHTSA | [67 FR 19697, Apr. 23, 2002] | (a) If notification is required by an order under 49 U.S.C. 30118(b) or is required under 49 U.S.C. 30118(c) and the manufacturer has provided to a dealer (including retailers of motor vehicle equipment) notification about a new motor vehicle or new item of replacement equipment in the dealer's possession, including actual and constructive possession, at the time of notification that contains a defect related to motor vehicle safety or does not comply with an applicable motor vehicle safety standard issued under 49 CFR part 571, the dealer may sell or lease the motor vehicle or item of replacement equipment only if: (1) The defect or noncompliance is remedied as required by 49 U.S.C. 30120 before delivery under the sale or lease; or (2) When the notification is required by an order under 49 U.S.C. 30118(b), enforcement of the order is restrained or the order is set aside in a civil action to which 49 U.S.C. 30121(d) applies. (b) Paragraph (a) of this section does not prohibit a dealer from offering the vehicle or equipment for sale or lease, provided that the dealer does not sell or lease it. | ||||||
| 49:49:7.1.1.1.2.0.1.12 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.12 Prohibition on sale or lease of new and used defective and noncompliant motor vehicle equipment. | NHTSA | [67 FR 19698, Apr. 23, 2002] | (a) Subject to § 573.12(b), no person may sell or lease any new or used item of motor vehicle equipment (including a tire) as defined by 49 U.S.C. 30102(a)(7), for installation on a motor vehicle, that is the subject of a decision under 49 U.S.C. 30118(b) or a notice required under 49 U.S.C. 30118(c), in a condition that it may be reasonably used for its original purpose. (b) Paragraph (a) of this section is not applicable where: (1) The defect or noncompliance is remedied as required under 49 U.S.C. 30120 before delivery under the sale or lease; (2) Notification of the defect or noncompliance is required by an order under 49 U.S.C. 30118(b), but enforcement of the order is restrained or the order is set aside in a civil action to which 49 U.S.C. 30121(d) applies. | ||||||
| 49:49:7.1.1.1.2.0.1.13 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.13 Reimbursement for pre-notification remedies. | NHTSA | [67 FR 64063, Oct. 17, 2002] | (a) Pursuant to 49 U.S.C. 30120(d) and § 573.6(c)(8)(i) of this part, this section specifies requirements for a manufacturer's plan (including general reimbursement plans submitted pursuant to § 573.6(c)(8)(i)) to reimburse owners and purchasers for costs incurred for remedies in advance of the manufacturer's notification of safety-related defects and noncompliance with Federal motor vehicle safety standards under subsection (b) or (c) of 49 U.S.C. 30118. (b) Definitions. The following definitions apply to this section: (1) Booster seat means either a backless child restraint system or a belt-positioning seat. (2) Claimant means a person who seeks reimbursement for the costs of a pre-notification remedy for which he or she paid. (3) Pre-notification remedy means a remedy that is performed on a motor vehicle or item of replacement equipment for a problem subsequently addressed by a notification under subsection (b) or (c) of 49 U.S.C. 30118 and that is obtained during the period for reimbursement specified in paragraph (c) of this section. (4) Other child restraint system means all child restraint systems as defined in 49 CFR 571.213 S4 not included within the categories of rear-facing infant seat or booster seat. (5) Rear-facing infant seat means a child restraint system that is designed to position a child to face only in the direction opposite to the normal direction of travel of the motor vehicle. (6) Warranty means a warranty as defined in § 579.4(c) of this chapter. (c) The manufacturer's plan shall specify a period for reimbursement, as follows: (1) The beginning date shall be no later than a date based on the underlying basis for the recall determined as follows: (i) For a noncompliance with a Federal motor vehicle safety standard, the date shall be the date of the first test or observation by either NHTSA or the manufacturer indicating that a noncompliance may exist. (ii) For a safety-related defect that is determined to exist following the opening of an Engineering Analysis (EA) by… | ||||||
| 49:49:7.1.1.1.2.0.1.14 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.14 Accelerated remedy program. | NHTSA | [67 FR 72392, Dec. 5, 2002] | (a) An accelerated remedy program is one in which the manufacturer expands the sources of replacement parts needed to remedy the defect or noncompliance, or expands the number of authorized repair facilities beyond those facilities that usually and customarily provide remedy work for the manufacturer, or both. (b) The Administrator may require a manufacturer to accelerate its remedy program if: (1) The Administrator finds that there is a risk of serious injury or death if the remedy program is not accelerated; (2) The Administrator finds that acceleration of the remedy program can be reasonably achieved by expanding the sources of replacement parts, expanding the number of authorized repair facilities, or both; and (3) The Administrator determines that the manufacturer's remedy program is not likely to be capable of completion within a reasonable time. (c) The Administrator, in deciding whether to require the manufacturer to accelerate a remedy program and what to require the manufacturer to do, will consult with the manufacturer and may consider a wide range of information, including, but not limited to, the following: the manufacturer's initial or revised report submitted under § 573.6(c), information from the manufacturer, information from other manufacturers and suppliers, information from any source related to the availability and implementation of the remedy, and the seriousness of the risk of injury or death associated with the defect or noncompliance. (d) As required by the Administrator, an accelerated remedy program shall include the manner of acceleration (expansion of the sources of replacement parts, expansion of the number of authorized repair facilities, or both), may require submission of a plan, may identify the parts to be provided and/or the sources of those parts, may require the manufacturer to notify the agency and owners about any differences among different sources or brands of parts, may require the manufacturer to identify additional authorized repair facilities, and may specify ad… | ||||||
| 49:49:7.1.1.1.2.0.1.15 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.15 Public availability of motor vehicle recall information. | NHTSA | [78 FR 51421, Aug. 20, 2013, as amended at 79 FR 43677, July 28, 2014] | (a) General —Manufacturers that have manufactured for sale, sold, offered for sale, introduced or delivered for introduction in interstate commerce, or imported into the United States 25,000 or more light vehicles or 5,000 or more motorcycles in the current calendar year or the prior calendar year shall make motor vehicle safety recall information applicable to the vehicles they manufactured available to the public on the Internet. The information shall be in a format that is searchable by vehicle make and model and vehicle identification number (VIN), that preserves consumer privacy, and that includes information about each recall that has not been completed for each vehicle. (b) Specific requirements —The system that manufacturers use to provide the information as specified in paragraph (a) of this section must also meet the following requirements: (1) Be free of charge and not require users to register or submit information, other than a make, model, and a VIN, in order to obtain information on recalls; (2) Have a hyperlink (Internet link) to it conspicuously placed on the manufacturer's main United States' Web page; (3) Not include sales or marketing messages with the page for entering a make, model, and VIN, or with the page where the results are displayed; (4) Allow users to search a vehicle's recall remedy status, and report that a recall has not been completed on that vehicle, as soon as possible and no later than the date when the manufacturer includes that vehicle on its list compiled for purposes of 49 CFR 573.8(a); (5) Ensure safety recalls subject to paragraph (b)(4) of this section are conspicuously placed first, before any other information that is displayed; (6) For vehicles that have been identified as covered by a safety recall, but for which the recall remedy is not yet available, state that the vehicle is covered by the safety recall and that the remedy is not yet available; (7) Be updated at least once every seven (7) calendar days. The date of the last update must display on both t… | ||||||
| 49:49:7.1.1.1.2.0.1.16 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.16 Reporting bankruptcy petition. | NHTSA | [78 FR 51422, Aug. 20, 2013] | Each manufacturer that files a bankruptcy petition, or is the subject of an involuntary petition for which relief has been ordered, pursuant to Title 11 of the United States Code, 11 U.S.C. 101 et seq., shall provide NHTSA a report as specified below. (a) The name of the court, the docket number, and the name, address and telephone number of the manufacturer's legal representative; (b) A copy of the bankruptcy petition; (c) A list of the recalls for which the manufacturer filed a “Defect and noncompliance information report” with NHTSA pursuant to 49 CFR 573.6; and (d) The information specified in 49 CFR 573.7(b) for each recall listed pursuant to paragraph (c) of this section. (e) Each report pursuant to this section must be received by NHTSA not more than 5 working days after the date the petition is filed in the United States Bankruptcy Court. Reports shall be addressed to the Associate Administrator for Enforcement, National Highway Traffic Safety Administration, Attention: Recall Management Division (NVS-215), 1200 New Jersey Ave. SE., Washington, DC 20590, or submitted as an attachment to an email message to RMD.ODI@dot.gov in a portable document format (.pdf). | ||||||
| 49:49:7.1.1.1.2.0.1.2 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.2 Purposes. | NHTSA | [67 FR 45872, July 10, 2002] | The purposes of this part are: (a) To facilitate the notification of owners of defective and noncomplying motor vehicles and items of motor vehicle equipment, and the remedy of such defects and noncompliances, by equitably apportioning the responsibility for safety-related defects and noncompliances with Federal motor vehicle safety standards among manufacturers of motor vehicles and motor vehicle equipment; and (b) To inform NHTSA of defective and noncomplying motor vehicles and items of motor vehicle equipment, and to obtain information for NHTSA on the adequacy of manufacturers' defect and noncompliance notification campaigns, on corrective action, on owner response, and to compare the defect incidence rate among different groups of vehicles. | ||||||
| 49:49:7.1.1.1.2.0.1.3 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.3 Application. | NHTSA | [43 FR 60169, Dec. 26, 1978, as amended at 60 FR 17268, Apr. 5, 1995; 66 FR 38162, July 23, 2001; 67 FR 19697, Apr. 23, 2002; 68 FR 18142, Apr. 15, 2003] | (a) Except as provided in paragraphs (g), (h), and (i) of this section, this part applies to manufacturers of complete motor vehicles, incomplete motor vehicles, and motor vehicle original and replacement equipment, with respect to all vehicles and equipment that have been transported beyond the direct control of the manufacturer. (b) In the case of a defect or noncompliance decided to exist in a motor vehicle or equipment item imported into the United States, compliance with §§ 573.6 and 573.7 by either the fabricating manufacturer or the importer of the vehicle or equipment item shall be considered compliance by both. (c) In the case of a defect or noncompliance decided to exist in a vehicle manufactured in two or more stages, compliance with §§ 573.6 and 573.7 by either the manufacturer of the incomplete vehicle or any subsequent manufacturer of the vehicle shall be considered compliance by all manufacturers. (d) In the case of a defect or noncompliance decided to exist in an item of replacement equipment (except tires) compliance with §§ 573.6 and 573.7 by the brand name or trademark owner shall be considered compliance by the manufacturer. Tire brand name owners are considered manufacturers (49 U.S.C. 10102(b)(1)(E)) and have the same reporting requirements as manufacturers. (e) In the case of a defect or noncompliance decided to exist in an item of original equipment used in the vehicles of only one vehicle manufacturer, compliance with §§ 573.6 and 573.7 by either the vehicle or equipment manufacturer shall be considered compliance by both. (f) In the case of a defect or noncompliance decided to exist in original equipment installed in the vehicles of more than one manufacturer, compliance with § 573.6 is required of the equipment manufacturer as to the equipment item, and of each vehicle manufacturer as to the vehicles in which the equipment has been installed. Compliance with § 573.7 is required of the manufacturer who is conducting the recall campaign. (g) The provisions of § 573.10 apply to all p… | ||||||
| 49:49:7.1.1.1.2.0.1.4 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.4 Definitions. | NHTSA | [43 FR 60169, Dec. 26, 1978, as amended at 60 FR 17268, Apr. 5, 1995; 67 FR 45872, July 10, 2002] | For purposes of this part: Act means 49 U.S.C. Chapter 301. Administrator means the Administrator of the National Highway Traffic Safety Administration or his delegate. First purchaser means first purchaser for purposes other than resale. Leased motor vehicle means any motor vehicle that is leased to a person for a term of at least four months by a lessor who has leased five or more vehicles in the twelve months preceding the date of notification by the vehicle manufacturer of the existence of a safety-related defect or noncompliance with a Federal motor vehicle safety standard in the motor vehicle. Lessee means a person who is the lessee of a leased motor vehicle as defined in this section. Lessor means a person or entity that is the owner, as reflected on the vehicle's title, of any five or more leased vehicles (as defined in this section), as of the date of notification by the manufacturer of the existence of a safety-related defect or noncompliance with a Federal motor vehicle safety standard in one or more of the leased motor vehicles. Original equipment means an item of motor vehicle equipment (other than a tire) that was installed in or on a motor vehicle at the time of its delivery to the first purchaser if the item of equipment was installed on or in the motor vehicle at the time of its delivery to a dealer or distributor for distribution, or was installed by the dealer or distributor with the express authorizations of the motor vehicle manufacturer. Readable form means a form readable by the unassisted eye or readable by machine. If readable by machine, the submitting party must obtain written confirmation from the Office of Defects Investigation immediately prior to submission that the machine is readily available to NHTSA. For all similar information responses, once a manufacturer has obtained approval for the original response in that form, it will not have to obtain approval for future submissions in the same form. In addition, all coded information must be accompanied by an explanat… | ||||||
| 49:49:7.1.1.1.2.0.1.5 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.5 Defect and noncompliance responsibility. | NHTSA | [67 FR 45872, July 10, 2002] | (a) Each manufacturer of a motor vehicle shall be responsible for any safety-related defect or any noncompliance determined to exist in the vehicle or in any item of original equipment. (b) Each manufacturer of an item of replacement equipment shall be responsible for any safety-related defect or any noncompliance determined to exist in the equipment. | ||||||
| 49:49:7.1.1.1.2.0.1.6 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.6 Defect and noncompliance information report. | NHTSA | [43 FR 60169, Dec. 26, 1978, as amended at 44 FR 20437, Apr. 5, 1979; 48 FR 44081, Sept. 27, 1983; 60 FR 17268, Apr. 5, 1995; 61 FR 278, Jan. 4, 1996. Redesignated at 67 FR 45872, July 10, 2002, as amended at 67 FR 64063, Oct. 17, 2002; 69 FR 34959, June 23, 2004; 69 FR 50084, Aug. 13, 2004; 70 FR 38814, July 6, 2005; 72 FR 32016, June 11, 2007; 74 FR 47757, Sept. 17, 2009; 78 FR 51421, Aug. 20, 2013; 79 FR 43677, July 28, 2014] | (a) Each manufacturer shall furnish a report to the NHTSA for each defect in his vehicles or in his items of original or replacement equipment that he or the Administrator determines to be related to motor vehicle safety, and for each noncompliance with a motor vehicle safety standard in such vehicles or items of equipment which either he or the Administrator determines to exist. (b) Each report shall be submitted not more than 5 working days after a defect in a vehicle or item of equipment has been determined to be safety related, or a noncompliance with a motor vehicle safety standard has been determined to exist. At a minimum, information required by paragraphs (c)(1), (2), and (5) of this section shall be submitted in the initial report. The remainder of the information required by paragraph (c) of this section that is not available within the five-day period shall be submitted within 5 working days after the manufacturer has confirmed the accuracy of the information. In addition, each manufacturer shall amend information required by paragraphs (c)(2), (3), and (8)(i) or (ii) within 5 working days after it has new information that updates or corrects information that was previously reported. Each manufacturer submitting new information relative to a previously submitted report shall refer to the recall campaign number when a number has been assigned by the NHTSA. (c) Each manufacturer shall include in each report the information specified below. (1) The manufacturer's name: The full corporate or individual name of the fabricating manufacturer and any brand name or trademark owner of the vehicle or item of equipment shall be spelled out, except that such abbreviations as “Co.” or “Inc.”, and their foreign equivalents, and the first and middle initials of individuals, may be used. In the case of a defect or noncompliance decided to exist in an imported vehicle or item of equipment, the agency designated by the fabricating manufacturer pursuant to 49 U.S.C. section 30164(a) shall be also stated. If the fabric… | ||||||
| 49:49:7.1.1.1.2.0.1.7 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.7 Quarterly reports. | NHTSA | [51 FR 398, Jan. 6, 1986, as amended at 60 FR 17269, Apr. 5, 1995. Redesignated at 67 FR 45872, July 10, 2002, as amended at 69 FR 50085, Aug. 13, 2004; 79 FR 43677, July 28, 2014] | (a) Each manufacturer who is conducting a defect or noncompliance notification campaign to manufacturers, distributors, dealers, or owners shall submit to NHTSA a report in accordance with paragraphs (b), (c), and (d) of this section. Unless otherwise directed by the NHTSA, the information specified in paragraphs (b)(1) through (5) of this section shall be included in the quarterly report, with respect to each notification campaign, for each of six consecutive quarters beginning with the quarter in which the campaign was initiated (i.e., the date the manufacturer notifies its purchasers of the availability of a remedy) or corrective action has been completed on all defective or noncomplying vehicles or items of replacement equipment involved in the campaign, whichever occurs first. (b) Each report shall include the following information identified by and in the order of the subparagraph headings of this paragraph. (1) The notification campaign number assigned by NHTSA. (2) The date notification began and the date completed. (3) The number of vehicles or items of equipment involved in the notification campaign. (4) The number of vehicles and equipment items which have been inspected and repaired and the number of vehicles and equipment items inspected and determined not to need repair. (5) The number of vehicles or items of equipment determined to be unreachable for inspection due to export, theft, scrapping, failure to receive notification, or other reasons (specify). The number of vehicles or items or equipment in each category shall be specified. (6) In reports by equipment manufacturers, the number of items of equipment repaired and/or returned by dealers, other retailers, and distributors to the manufacturer prior to their first sale to the public. (7) For all recalls that involve the replacement of tires, the manufacturer shall provide: (i) The aggregate number of recalled tires that the manufacturer becomes aware have not been rendered unsuitable for resale for installation on a motor vehicle in ac… | ||||||
| 49:49:7.1.1.1.2.0.1.8 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.8 Lists of purchasers, owners, dealers, distributors, lessors, and lessees. | NHTSA | [43 FR 60169, Dec. 26, 1978, as amended at 44 FR 20437, Apr. 5, 1979; 60 FR 17269, Apr. 5, 1995; 61 FR 278, Jan. 4, 1996. Redesignated at 67 FR 45872, July 10, 2002; 69 FR 34959, June 23, 2004] | (a) Each manufacturer of motor vehicles shall maintain, in a form suitable for inspection such as computer information storage devices or card files, a list of the names and addresses of registered owners, as determined through State motor vehicle registration records or other sources or the most recent purchasers where the registered owners are unknown, for all vehicles involved in a defect or noncompliance notification campaign initiated after the effective date of this part. The list shall include the vehicle identification number for each vehicle and the status of remedy with respect to each vehicle, updated as of the end of each quarterly reporting period specified in § 573.7. Each vehicle manufacturer shall also maintain such a list of the names and addresses of all dealers and distributors to which a defect or noncompliance notification was sent. Each list shall be retained for 5 years, beginning with the date on which the defect or noncompliance information report required by § 573.6 is initially submitted to NHTSA. (b) Each manufacturer (including brand name owners) of tires shall maintain, in a form suitable for inspection such as computer information storage devices or card files, a list of the names and addresses of the first purchasers of his tires for all tires involved in a defect or noncompliance notification campaign initiated after the effective date of this part. The list shall include the tire identification number of all tires and shall show the status of remedy with respect to each owner involved in each notification campaign, updated as of the end of each quarterly reporting period specified in § 573.6. Each list shall be retained, beginning with the date on which the defect information report is initially submitted to the NHTSA, for 3 years. (c) For each item of equipment involved in a defect or noncompliance notification campaign initiated after the effective date of this part, each manufacturer of motor vehicle equipment other than tires shall maintain, in a form suitable for inspectio… | ||||||
| 49:49:7.1.1.1.2.0.1.9 | 49 | Transportation | V | 573 | PART 573—DEFECT AND NONCOMPLIANCE RESPONSIBILITY AND REPORTS | § 573.9 Address for submitting required reports and other information. | NHTSA | [78 FR 51421, Aug. 20, 2013] | All submissions, except as otherwise required by this part, shall be submitted to NHTSA on the Internet Web page http://www.safercar.gov/Vehicle + Manufacturers. A manufacturer must use the templates provided at this Web page for all submissions required under this section. Defect and noncompliance information reports required by § 573.6 of this part shall be submitted using one of the following forms, depending upon the type of product that is the subject of the report: “Defect and/or Noncompliance Information Report Form—Vehicles;” “Defect and/or Noncompliance Information Report Form—Equipment;” “Defect and/or Noncompliance Information Report Form—Tires;” “Defect and/or Noncompliance Information Report Form—Child Restraints;” “Defect and/or Noncompliance Information Report—Vehicle Alterers.” Reports required under § 573.7 of this part shall be submitted using the form, “Quarterly Report Form” also located at this Web page. |
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title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
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