Electronic Code of Federal Regulations:

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.

(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.

(c) It is used as a thickener and suspending agent in nonmedicated aqueous suspensions intended for addition to animal feeds.

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.

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:

(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.

(i) That not more than one-third of the total protein in the feed should come from nonprotein nitrogen sources.

(iii) “Warning—This feed should be used only in accordance with directions furnished on the label.”

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:

(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.”

(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.

(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 from nonprotein nitrogen, and directions for use consistent with this section.

(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:

(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:

(2) Adequate directions for use including maximum quantities permitted for each species and a guaranteed analysis of the additive.

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:

	Percent
Biuret	55 minimum.
Urea	15 maximum.
Cyanuric acid and triuret	30 maximum.
Mineral oil	0.5 maximum.
Total nitrogen (equivalent to 218.75 pct crude protein)	35 minimum.

(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:

(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.

The food additive 1,3-butylene glycol (1,3-butanediol) may be safely used in accordance with the following prescribed conditions:

(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.

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.

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.

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.

(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.

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.

(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.

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:

(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:

(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.”

(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:

(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.

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 (C₁₀H₁₄O₈N₂Na₂·2H₂O).

(b) It is used to solubilize trace minerals in aqueous solutions, which are then added to animal feeds.

(2) Adequate mixing directions to ensure that the chelated trace-mineral mix is uniformly blended throughout the feed.

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:

(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.”

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:

Alfalfa	Medicago sativa.
Barley	Hordeum vulgare.
Clovers:
Alsike clover	Trifolium hybridum.
Crimson clover	Trifolium incarnatum.
Red clover	Trifolium pratense.
White clover (including Ladino)	Trifolium repens.
White sweetclover	Melilotus alba.
Yellow sweetclover	Melilotus officinalis.
Coastal Bermudagrass	Cynodon dactylon.
Corn	Zea mays.
Fescue	Festuca sp.
Oats	Avena sativa.
Orchardgrass	Dactylis glomerata.
Reed canarygrass	Pharlaris arundinacea.
Ryegrass (annual and perennial)	Elymus sp. and Lolium perenne.
Sorghums	Sorghum vulgare vars, feterita, shallu, kaoliang, broomcorn.
Sudan grass	Sorghum vulgare sudanense.
Wheat	Triticum aestivum.

(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:

(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.”

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 (OC₂H₅) 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 as a binder or filler in dry vitamin preparations to be incorporated into animal feed.

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.

(a) Identity. The product is produced by the Lactobacillus bulgaricus 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.

(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.

(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:

(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.

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 Division of Dockets Management, 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:

(B) Adequate directions for use providing that the feed as consumed does not contain more than 25 percent of the mixture.

(2) For soybean and canola seeds and/or meals to which there may be added vegetable oil as a component of dry, nonpelleted feeds for beef and dairy cattle, including lactating dairy cattle.

(i) An aqueous blend of oilseed and/or meals, with or without added vegetable oil, in a ratio such that, on a dry matter basis, the final protein level will be 25 to 35 percent and the fat content will be 20 to 45 percent. The feed ingredients are those defined by the “Official Publication” of the Association of American Feed Control Officials, Inc., 2003 ed., pp. 301, 307, 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 Division of Dockets Management, 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 2.7 percent of the dry matter weight basis of the oilseeds and/or meals and the vegetable oil. This mixture, upon drying, contains not more than 0.5 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 act, the label and labeling of the dried mixture shall bear:

(B) The statement, “This supplement is not to exceed 12.5% of the total ration. Dietary calcium and magnesium levels should be considered when supplementing the diet with fat.”

(C) The minimum and maximum levels of crude fat must be guaranteed and must be between -5 percent and +5 percent of the analyzed fat content for each batch.

(b)(1) The food additive is formaldehyde (CAS No. 50–00–0; 37 percent aqueous solution). It is used at a rate of 5.4 pounds (2.5 kilograms) per ton of animal feed or feed ingredient. It is an antimicrobial agent used to maintain complete animal feeds or feed ingredients Salmonella negative for up to 21 days.

(2) To assure safe use of the additive, in addition to the other information required by the Act, the label and labeling shall contain:

(ii) A statement that formaldehyde solution which has been stored below 40 °F or allowed to freeze should not be applied to complete animal feeds or feed ingredients.

(iii) Adequate directions for use including a statement that formaldehyde should be uniformly sprayed on and thoroughly mixed into the complete animal feeds or feed ingredients and that the complete animal feeds or feed ingredients so treated shall be labeled as containing formaldehyde. The label must prominently display the statement: “Treated with formaldehyde to maintain feed Salmonella negative. Use within 21 days.”

(iv) The labeling for feed or feed ingredients to which formaldehyde has been added under the provisions of paragraph (b)(1) of this section is required to carry the following statement: “Treated with formaldehyde to maintain feed Salmonella negative. Use within 21 days.”

(3) To assure safe use of the additive, in addition to the other information required by the Act, the label and labeling shall contain:

(ii) Statements identifying formaldehyde as a poison with potentials for adverse respiratory effects.

(iv) Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration's (OSHA) human safety guidance regulations.

(v) Contact address and phone number for reporting adverse reactions or to request a copy of the Materials Safety Data Sheet (MSDS).

[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]

Formic acid may be safely 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. The top foot of silage stored should not contain formic acid and silage should not be fed to livestock within 4 weeks of treatment.

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 lilium used to produce the glutamic acid.

(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:

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.

(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.

(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:

(2) Adequate directions for use in accordance with the provisions in paragraph (d) of this section.

(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:

(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:

(2) Adequate directions to provide finished feeds complying with paragraph (c) of this section.

Iron ammonium citrate may be safely used in animal feed in accordance with the following prescribed conditions:

(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:

(2) Adequate directions to provide a final product that complies with the limitations prescribed in paragraph (b) of this section.

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.

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 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 growing and finishing swine as a source of fatty acids at levels not to exceed 0.6% in the finished feed.

(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:

(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.

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.

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 (C₁₇H₁₈O₆N₂S).

(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.

(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.

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.

(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.

(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 is incorporated by reference, shall be employed. (Copies of the methods are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspectionat the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ) The presence of chick-edema factor shall be determined by a comparison between the mean log of the pericardial fluid volumes of a test group and of a concurrent negative control group. The significance of the difference in pericardial fluid volumes between the test group and the negative control group is determined by calculating a “t” value according to the formula:

x tand x care the means of the logs of the pericardial fluid volumes of the test and control groups, respectively;

Σ x ² is the sum of the squares of the logs of the pericardial fluid volumes for either the test t or control c group data.

The test sample is judged to contain chick-edema factor if the calculated “t” exceeds +1.3 and the mean log of the pericardial fluid volume obtained from the negative control group multiplied by 100 is less than 1.1461.

(iii) “Other factors toxic to chicks” referred to in paragraph (b)(3) of this section shall be determined during the course of the bioassay test described in paragraph (b)(4)(ii) of this section, on the basis of chick deaths or other abnormalities not attributable to chick-edema factor or to the experimental conditions of the test.

(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 additive supplement, feed additive concentrate, feed additive premix, or complete feed prepared therefrom shall bear:

(ii) The designation “feed grade” in juxtaposition with the name and equally as prominent.

(2) The label or labeling of the additive and any feed additive supplement, feed additive concentrate, feed additive premix, or complete feed prepared therefrom shall bear adequate directions for use.

[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]

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.

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.

(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.

(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.

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[22.3.1.0⁵ ,⁷ ] octacosa-8,14,16,18,20-pentaene-25-carboxylic acid with the empirical formula C₃₃H₄₇NO₁₃.

(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:

(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.”

(6) A contact address and telephone number for reporting adverse reactions experienced by users, or to request a copy of the Material Safety Data Sheet for natamycin.

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:

(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.

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.

(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.

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.

(a) Identity . The food additive Pichia pastoris dried yeast 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:

(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.”

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:

(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.

(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:

(d) Labeling. The labels and labeling shall bear in addition to the other information required by the Act:

(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.

(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.

The food additive polyoxyethylene glycol (400) mono- and dioleates may be safely used as an emulsifier in calf-milk replacer formulations.

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.

The food additive polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) may be safely used as an emulsifier in milk-replacer formulations for calves.

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:

Component/property	Limitation
Inherent viscosity	1.0-1.6 deciliter per gram.¹
Styrene moiety	40 percent maximum.
2-Vinylpyridine moiety.	90 percent maximum.
Residual styrene	200 parts per billion maximum.
Residual 2-vinylstyrene	200 parts per billion maximum.
Heavy metals such as lead	10 parts per million maximum.
Arsenic	3 parts per million maximum.

¹Inherent 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:

(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) The following statement: “Warning: Maximum use of poly(2-vinylpyridine-co-styrene) from all sources is not to exceed 5.1 grams per head per day.”

[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]

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.

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.

(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:

Components	Amount
Ammonium salts of mixed 5-carbon acids (as identified in paragraph (a) of this section)	48 to 54 percent.
Ammonium salt of isobutyric acid	22 to 26 percent.
Water	28 percent maximum.
Ammonia	0.3 percent maximum.
Arsenic	3 parts per million maximum.
Heavy metals such as lead	10 parts per million maximum.

Components	Amount
Calcium salts of mixed 5-carbon acids (as identified in paragraph (a) of this section)	58 to 72 percent.
Calcium salt of isobutyric acid	26 to 34 percent.
Calcium hydroxide	3 percent maximum.
Water	14 percent maximum.
Arsenic	3 parts per million maximum.
Heavy metals such as lead	10 parts per million maximum.

(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:

(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.”

[49 FR 45125, Nov. 15, 1984; 50 FR 8606, Mar. 4, 1985, as amended at 70 FR 13100, Mar. 18, 2005]

(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;

(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 (g) 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 or in a controlled-release sodium selenite bolus, as provided in paragraphs (f) and (g) of this section, or as selenium yeast, as provided in paragraph (h) of this section.

(1) In complete feed for chickens, swine, turkeys, sheep, cattle, and ducks at a level not to exceed 0.3 part per million.

(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.

(i) Sheep: Up to 90 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 0.7 milligram per head per day.

(ii) Beef cattle: Up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 3 milligrams per head per day.

(1) It shall be incorporated into each ton of complete feed by adding no less than 1 pound of a premix containing no more than 272.4 milligrams of added selenium per pound.

(2) It shall be incorporated into each ton of salt-mineral mixture for sheep or beef cattle from a premix containing no more than 4.5 grams of added selenium per pound.

(e) The premix manufacturer shall follow good manufacturing practices in the production of selenium premixes. Inventory, production, and distribution records must provide a complete and accurate history of product production. Production controls must assure products to be what they are purported and labeled. Production controls shall include analysis sufficient to adequately monitor quality.

(f) The label or labeling of any selenium premix shall bear adequate directions and cautions for use including this statement: “Caution: Follow label directions. The addition to feed of higher levels of this premix containing selenium is not permitted.”

(g) The additive is orally administered to beef and dairy cattle as an osmotically controlled, constant release bolus containing sodium selenite. Each bolus contains 360 milligrams of selenium as sodium selenite, and delivers 3 milligrams of selenium per day for 120 days. To ensure safe use of the additive:

(1) The osmotically controlled, constant release bolus is for use only in beef and dairy cattle more than 3 months of age or over 200 pounds body weight.

(2) Only one bolus containing 360 milligrams of selenium as sodium selenite is administered orally to each animal in 120 days.

(3) The labeling shall bear the following: “This bolus delivers the maximum daily allowable amount of selenium and shall be the sole source of supplementation. Do not use in areas containing excess selenium. Do not rebolus within 4 months.”

(h) Selenium yeast is a dried, non-viable yeast ( Saccharomyces cerevisiae ) cultivated in a fed-batch fermentation which provides incremental amounts of cane molasses and selenium salts in a manner which minimizes the detrimental effects of selenium salts on the growth rate of the yeast and allows for optimal incorporation of inorganic selenium into cellular organic material. Residual inorganic selenium is eliminated in a rigorous washing process and must not exceed 2 percent of the total selenium content in the final selenium yeast product.

(i) In complete feed for chickens, turkeys, swine, beef cattle, and dairy cattle at a level not to exceed 0.3 part per million.

(ii) In feed supplements for limit feeding for beef cattle at a level not to exceed an intake of 3 milligrams per head per day.

(iii) In salt-mineral mixtures for free-choice feeding for beef cattle up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 3 milligrams per head per day.

(2) Guaranteed organic selenium content from selenium yeast must be declared on the selenium yeast product label.

(3) The additive, as selenium yeast, shall be incorporated into feed as follows:

(i) It shall be incorporated into each ton of complete feed by adding no less than 1 pound of a premix containing no more than 272.4 milligrams of added selenium per pound.

(ii) It shall be incorporated into each ton of salt-mineral mixture for beef cattle from a premix containing no more than 4.5 grams of added selenium per pound.

(4) Usage of this additive must conform to the requirements of paragraphs (e) and (f) of this section.

[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]

Effective Date Note: At 58 FR 47973, Sept. 13, 1993, the amendments to §573.920 that were published at 52 FR 10887, Apr. 6, 1987; 52 FR 21001, June 4, 1987; and 54 FR 14214, Apr. 10, 1989 were stayed until further notice. At 59 FR 45973, Sept. 6, 1994, the stay was confirmed.

§ 573.940 Silicon dioxide.

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 in feed components as an anticaking agent, and/or grinding aid, as follows:

Feed component	Limitations (percent)
BHT (butylated hydroxytoluene)	2
Methionine hydroxy analog and its calcium salts	1
Piperazine, piperazine salts	0.8
Sodium propionate	1
Urea	1
Vitamins	3

(c) It is used in feed as an anticaking agent in an amount not to exceed that reasonably required to accomplish its intended effect and in no case in an amount to exceed 2 percent by weight of the finished feed.

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.

The food additive taurine (2-amino-ethanesulfonic acid) may be safely used in feed in accordance with the following prescribed conditions:

(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:

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.

( 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 directions for use, and, when the additive is present in excess of 1 percent, a statement of the quantity of the additive contained therein and the term “nonnutritive” in juxtaposition therewith.

(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:

(2) In liquid feed supplements for ruminant animals at a maximum use level of 0.25 percent (5 pounds per ton).

(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.

Yellow prussiate of soda (sodium ferrocyanide decahydrate: Na₄Fe(Cn)₆°-10H₂O) 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.

PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS

Subpart A [Reserved]

Subpart B—Food Additive Listing

§ 573.120 Acrylamide-acrylic acid resin.

§ 573.130 Aminoglycoside 3′-phospho- transferase II.

§ 573.140 Ammoniated cottonseed meal.

§ 573.160 Ammoniated rice hulls.

§ 573.180 Anhydrous ammonia.

§ 573.200 Condensed animal protein hydrolysate.

§ 573.220 Feed-grade biuret.

§ 573.225 1,3-Butylene glycol.

§ 573.240 Calcium periodate.

§ 573.260 Calcium silicate.

§ 573.280 Feed-grade calcium stearate and sodium stearate.

§ 573.300 Choline xanthate.

§ 573.310 Crambe meal, heat toasted.

§ 573.320 Diammonium phosphate.

§ 573.340 Diatomaceous earth.

§ 573.360 Disodium EDTA.

§ 573.380 Ethoxyquin in animal feeds.

§ 573.400 Ethoxyquin in certain dehydrated forage crops.

§ 573.420 Ethyl cellulose.

§ 573.440 Ethylene dichloride.

§ 573.450 Fermented ammoniated condensed whey.

§ 573.460 Formaldehyde.

§ 573.480 Formic acid.

§ 573.500 Condensed, extracted glutamic acid fermentation product.

§ 573.520 Hemicellulose extract.

§ 573.530 Hydrogenated corn syrup.

§ 573.540 Hydrolyzed leather meal.

§ 573.560 Iron ammonium citrate.

§ 573.580 Iron-choline citrate complex.

§ 573.637 Methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12-octadecadienoic acids).

§ 573.600 Lignin sulfonates.

§ 573.620 Menadione dimethylpyrimidinol bisulfite.

§ 573.625 Menadione nicotinamide bisulfite.

§ 573.640 Methyl esters of higher fatty acids.

§ 573.660 Methyl glucoside-coconut oil ester.

§ 573.680 Mineral oil.

§ 573.685 Natamycin.

§ 573.700 Sodium nitrite.

§ 573.720 Petrolatum.

§ 573.740 Odorless light petroleum hydrocarbons.

§ 573.750 Pichia pastoris dried yeast.

§ 573.760 Poloxalene.

§ 573.780 Polyethylene.

§ 573.800 Polyethylene glycol (400) mono- and dioleate.

§ 573.820 Polyoxyethylene glycol (400) mono- and dioleates.

§ 573.840 Polysorbate 60.

§ 573.860 Polysorbate 80.

§ 573.870 Poly(2-vinylpyridine-co-styrene).

§ 573.880 Normal propyl alcohol.

§ 573.900 Pyrophyllite.

§ 573.914 Salts of volatile fatty acids.

§ 573.920 Selenium.

§ 573.940 Silicon dioxide.

§ 573.960 Sorbitan monostearate.

§ 573.980 Taurine.

§ 573.1000 Verxite.

§ 573.1010 Xanthan gum.

§ 573.1020 Yellow prussiate of soda.