540 Part 573—Food Additives

§ 571.110 21 CFR Ch. I (4–1–10 Edition)

§ 571.110 Procedure for objections and 573.130 Aminoglycoside 3′-phospho- trans- hearings. ferase II. 573.140 Ammoniated cottonseed meal. Objections and hearings relating to 573.160 Ammoniated rice hulls. food additive regulations under section 573.180 Anhydrous ammonia. 409(c), (d), or (h) of the act shall be gov- 573.200 Condensed animal protein hydroly- erned by part 12 of this chapter. sate. 573.220 Feed-grade biuret. [42 FR 4717, Jan. 25, 1977, as amended at 42 573.225 1,3-Butylene glycol. FR 15676, Mar. 22, 1977] 573.240 Calcium periodate. 573.260 Calcium silicate. § 571.115 Application of the cancer 573.280 Feed-grade calcium stearate and so- clause of section 409 of the act. dium stearate. Food additives intended for use as an 573.300 Choline xanthate. ingredient in food for animals that are 573.310 Crambe meal, heat toasted. 573.320 Diammonium phosphate. raised for food production and that 573.340 Diatomaceous earth. have the potential to contaminate 573.360 Disodium EDTA. human food with residues whose con- 573.380 Ethoxyquin in animal feeds. sumption could present a risk of cancer 573.400 Ethoxyquin in certain dehydrated to people must satisfy the require- forage crops. ments of subpart E of part 500 of this 573.420 Ethyl cellulose. chapter. 573.440 Ethylene dichloride. 573.450 Fermented ammoniated condensed [52 FR 49588, Dec. 31, 1987] whey. 573.460 Formaldehyde. § 571.130 Procedure for amending and 573.480 Formic acid. repealing tolerances or exemptions 573.500 Condensed, extracted glutamic acid from tolerances. fermentation product. 573.520 Hemicellulose extract. (a) The Commissioner, on his own 573.530 Hydrogenated corn syrup. initiative or on the petition of any in- 573.540 Hydrolyzed leather meal. terested person, pursuant to part 10 of 573.560 Iron ammonium citrate. this chapter, may propose the issuance 573.580 Iron-choline citrate complex. of a regulation amending or repealing a 573.600 Lignin sulfonates. regulation pertaining to a food additive 573.620 Menadione dimethylpyrimidinol bi- or granting or repealing an exception sulfite. 573.625 Menadione nicotinamide bisulfite. for such additive. 573.637 Methyl esters of conjugated linoleic (b) Any such petition shall include an acid (cis-9, trans-11 and trans-10, cis-12- assertion of facts, supported by data, octadecadienoic acids). showing that new information exists 573.640 Methyl esters of higher fatty acids. with respect to the food additive or 573.660 Methyl glucoside-coconut oil ester. that new uses have been developed or 573.680 Mineral oil. old uses abandoned, that new data are 573.685 Natamycin. 573.700 Sodium nitrite. available as to toxicity of the chem- 573.720 Petrolatum. ical, or that experience with the exist- 573.740 Odorless light petroleum hydro- ing regulation or exemption may jus- carbons. tify its amendment or repeal. New data 573.750 Pichia pastoris dried yeast. shall be furnished in the form specified 573.760 Poloxalene. in § 571.1 for submitting petitions. 573.780 Polyethylene. 573.800 Polyethylene glycol (400) mono- and [42 FR 4717, Jan. 25, 1977; 42 FR 15676, Mar. 22, dioleate. 1977] 573.820 Polyoxyethylene glycol (400) mono- and dioleates. PART 573—FOOD ADDITIVES PER- 573.840 Polysorbate 60. 573.860 Polysorbate 80. MITTED IN FEED AND DRINKING 573.870 Poly(2-vinylpyridine-co-styrene). WATER OF ANIMALS 573.880 Normal propyl alcohol. 573.900 Pyrophyllite. Subpart A [Reserved] 573.914 Salts of volatile fatty acids. 573.920 Selenium. Subpart B—Food Additive Listing 573.940 Silicon dioxide. 573.960 Sorbitan monostearate. Sec. 573.980 Taurine. 573.120 Acrylamide-acrylic acid resin. 573.1000 Verxite.

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573.1010 Xanthan gum. kanr gene originally isolated from 573.1020 Yellow prussiate of soda. transposon Tn5 of the bacterium Esch- AUTHORITY: 21 U.S.C. 321, 342, 348. erichia coli. (c) The level of the additive does not SOURCE: 41 FR 38652, Sept. 10, 1976, unless otherwise noted. exceed the amount reasonably required for selection of plant cells carrying the kanr gene along with the genetic mate- Subpart A [Reserved] rial of interest. Subpart B—Food Additive Listing [59 FR 26711, May 23, 1994] § 573.120 Acrylamide-acrylic acid § 573.140 Ammoniated cottonseed resin. meal. Acrylamide-acrylic acid resin The food additive ammoniated cot- (hydrolized polyacrylamide), only for tonseed meal may be safely used in ac- the purposes of this section as de- cordance with the following conditions: scribed below, may be safely used in ac- (a) The food additive is the product cordance with the following prescribed obtained by the treatment of cotton- conditions: seed meal with anhydrous ammonia (a) The additive is produced by po- until a pressure of 50 pounds per square lymerization of acrylamide with par- inch gauge is reached. tial hydrolysis, or by copolymerization (b) It is used or intended for use in of acrylamide and acrylic acid with the the feed of ruminants as a source of greater part of the polymer being com- protein and/or as a source of non- posed of acrylamide units. protein nitrogen in an amount not to (b) The additive meets the following exceed 20 percent of the total ration. specifications: (c) To assure safe use, the label and (1) A minimum molecular weight of 3 labeling of the additive and of any feed million. additive supplement, concentrate, or (2) Viscosity range: 3,000 to 6,000 cen- premix prepared therefrom shall bear, tipoises at 77 °F in a 1 percent aqueous in addition to the other information re- solution as determined by LVF Brook- quired by the act, the following: field Viscometer or equivalent using a (1) The name of the additive. number 6 spindle at 20 r.p.m. (2) The maximum percentage of (3) Residual acrylamide: Not more equivalent crude protein from the non- than 0.05 percent. protein nitrogen. (c) It is used as a thickener and sus- (3) Directions for use to provide not pending agent in nonmedicated aque- more than 20 percent of the additive in ous suspensions intended for addition the total ration. to animal feeds. (4) A statement: (i) That not more than one-third of [41 FR 38652, Sept. 10, 1976, as amended at 45 the total protein in the feed should FR 38058, June 6, 1980] come from nonprotein nitrogen § 573.130 Aminoglycoside 3′-phospho- sources. transferase II. (ii) That the additive is not to be The food additive aminoglycoside 3′- given to debilitated or starved animals. phosphotransferase II may be safely (iii) ‘‘Warning—This feed should be used in the development of genetically used only in accordance with directions modified cotton, oilseed rape, and to- furnished on the label.’’ matoes in accordance with the fol- [41 FR 38652, Sept. 10, 1976, as amended at 42 lowing prescribed conditions: FR 52397, Sept. 30, 1977] (a) The food additive is the enzyme aminoglycoside 3′-phosphotransferase § 573.160 Ammoniated rice hulls. II (CAS Reg. No. 58943–39–8) which cata- The food additive ammoniated rice lyzes the phosphorylation of certain hulls may be safely used in accordance aminoglycoside antibiotics, including with the following prescribed condi- kanamycin, neomycin, and gentamicin. tions: (b) Aminoglycoside 3′- (a) The food additive is the product phosphotransferase II is encoded by the obtained by the treatment of ground

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rice hulls with monocalcium phosphate (ii) The anhydrous ammonia is ap- and anhydrous ammonia at a tempera- plied at a rate not to exceed the equiv- ture of 350 °F and a pressure of 175 alent of 0.35 percent of the corn plant pounds per square inch. material. (b) It is used or intended for use in (iii) It is applied to corn plant mate- the feed of beef cattle as a source of rial containing 30 to 35 percent dry crude fiber and as the sole source of matter. nonprotein nitrogen in an amount not (iv) It is applied so that 75 to 85 per- to exceed 20 percent of the total ration. cent of the additive is liquid at ambi- (c) To assure safe use of the additive, ent pressure. the label and labeling of the additive (3)(i) The food additive anhydrous and of any feed additive supplement, ammonia is applied after being diluted feed additive concentrate, or feed addi- to a 15 to 30 percent aqueous ammonia tive premix prepared therefrom, shall solution (by weight). contain, in addition to other informa- (ii) The anhydrous ammonia solution tion required by the act, the following: is applied at a rate not to exceed anhy- (1) The name of the additive. drous ammonia equivalent to 0.3 per- (2) The maximum percentage of cent of the corn plant material. equivalent crude protein from the non- (iii) It is applied to corn plant mate- protein nitrogen. rial containing 28 to 38 percent dry (3) Directions for use to provide not matter. more than 20 percent of the additive in (iv) The silage treated with aqueous the total ration, and a prominent ammonia is to be fed to dairy cattle statement: ‘‘Warning—This feed should only. be used only in accordance with the di- (b) Its labeling shall bear, in addition rections furnished on the label.’’ to the other requirements of the act, § 573.180 Anhydrous ammonia. the name of the additive, the concentration of ammonia, the maximum (a) The food additive anhydrous am- percentage of equivalent crude protein monia is applied directly to corn plant from nonprotein nitrogen, and direc- material and thoroughly blended prior tions for use consistent with this sec- to ensiling. It is used or intended for tion. use as a source of nonprotein nitrogen in cattle feed in accordance with para- [44 FR 40284, July 10, 1979] graphs (a)(1), (2), or (3) as follows: (1)(i) The food additive anhydrous § 573.200 Condensed animal protein ammonia is applied as a component of hydrolysate. an aqueous premix containing 16 to 17 (a) Identity. The condensed animal percent ammonia, with molasses, min- protein hydrolysate is produced from erals, and not less than 83 percent the meat byproducts scraped from crude protein. The premix is a source cured (salted) hides taken from cattle of nonprotein nitrogen and minerals. slaughtered for food consumption. The (ii) In addition to the requirements of meat byproduct is hydrolyzed with paragraph (b) of this section, the label- heat and phosphoric acid. ing shall bear an expiration date of not (b) Specifications. The additive shall more than 10 weeks after date of manu- conform to the following percent-by- facture; a statement that additional weight specifications: protein should not be fed to lactating dairy cows producing less than 32 Moisture, not less than 45 percent nor more pounds of milk per day nor beef cattle than 50 percent. consuming less than 1 percent of body Protein, not less than 24 percent. Salt (NaCl), not more than 15 percent. weight daily in shelled corn; and a Phosphorus, not less than 2.25 percent. warning not to use additional trace mineral supplementation with treated (c) Uses. It is used or intended for use silage. as a source of animal protein, phos- (2)(i) The food additive anhydrous phorus, and salt (NaCl) as follows: ammonia is applied directly to corn (1) In poultry and swine feed in an plant material for use in dairy or beef amount not to exceed 5 percent by cattle rations. weight of the feed.

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(2) In feed concentrates for cattle in (a) It complies with the specifica- an amount not to exceed 10 percent by tions in § 173.220(a) of this chapter. weight of the concentrate. (b) It is intended for use in swine feed (d) Labeling. The label and labeling as a source of energy. shall bear, in addition to the other in- (c) It is to be thoroughly mixed into formation required by the act: feed at levels not to exceed 9 percent of (1) The name of the additive, con- the dry matter of the total ration. densed animal protein hydrolysate. (d) 1,3-Butylene glycol should be (2) Adequate directions for use in- mixed in feed with equipment adapted cluding maximum quantities permitted for the addition of liquids, and the feed for each species and a guaranteed anal- should be mixed not less than 5 min- ysis of the additive. utes after its addition.

§ 573.220 Feed-grade biuret. [53 FR 40061, Oct. 13, 1988] The food additive feed grade biuret § 573.240 Calcium periodate. may be safely used in ruminant feed in The food additive calcium periodate accordance with the following pre- may be safely used in accordance with scribed conditions: the following prescribed conditions: (a) The food additive is the product (a) The additive is produced by react- resulting from the controlled pyrolysis ing calcium iodate with calcium hy- of urea conforming to the following droxide or calcium oxide to form a sub- specifications: stance consisting of not less than 60 Percent percent by weight of penta calcium orthoperiodate containing 28 to 31 per- Biuret ...... 55 minimum. cent by weight of iodine. Urea ...... 15 maximum. Cyanuric acid and triuret ...... 30 maximum. (b) It is used or intended for use in Mineral oil ...... 0.5 maximum. salt for livestock as a source of iodine. Total nitrogen (equivalent to 218.75 pct 35 minimum. crude protein). § 573.260 Calcium silicate. Calcium silicate, including synthetic (b) It is used in ruminant feeds as a calcium silicate, may be safely used as source of nonprotein nitrogen. an anticaking agent in animal feed, (c) To assure safe use of the additive: provided that the amount of calcium (1) The label and labeling of the addi- silicate does not exceed 2 percent. tive and that of any feed additive supplement, feed additive concentrate, § 573.280 Feed-grade calcium stearate feed additive premix, or complete feed and sodium stearate. prepared therefrom shall contain, in Feed-grade calcium stearate and so- addition to other information required dium stearate may be safely used in an by the act, the following: animal feed in accordance with the fol- (i) The name of the additive. lowing prescribed conditions: (ii) The maximum percentage of (a) Feed-grade calcium stearate and equivalent crude protein from non- sodium stearate are the calcium or so- protein nitrogen. dium salts of a fatty acid mixture that (2) The label shall recommend that is predominately stearic acid. Associ- the diet be balanced to provide ade- ated fatty acids, including palmitic quate nutrients when equivalent crude acid and minor amounts of lauric, protein from all forms of nonprotein myristic, pentadecanoic, margaric, nitrogen exceed one-third of the total arachidic, and other fatty acids may be crude protein in the total daily ration. contained in the mixture, but such as- [41 FR 38652, Sept. 10, 1976, as amended at 68 sociated fatty acids in aggregate do not FR 27904, May 22, 2003] exceed 35 percent by weight of the mixture. The fatty acids may be derived § 573.225 1,3-Butylene glycol. from feed-grade fats or oils. The food additive 1,3-butylene glycol (b) The additives meet the following (1,3-butanediol) may be safely used in specifications: accordance with the following pre- (1) Unsaponifiable matter does not scribed conditions: exceed 2 percent.

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(2) They are free of chick-edema fac- acid with anhydrous ammonia. It con- tor. tains not less than 106.25 percent equiv- (c) The additives are manufactured so alent crude protein (nitrogen × 6.25) that in aqueous solution they are ex- and 20 percent phosphorus. It contains posed for 1 hour or longer to tempera- not more than the following: ture in excess of 180 °F. 1 part fluorine to 100 parts phosphorus. (d) They are used as anticaking 75 parts per million or arsenic (as As). agents in animal feeds in accordance 30 parts per million of heavy metals, as lead with current good manufacturing prac- (Pb). tices. (b) It is used in ruminant feeds as a [63 FR 8573, Feb. 20, 1998] source of phosphorus and nitrogen in an amount that supplies not more than § 573.300 Choline xanthate. 2 percent of equivalent crude protein in Choline xanthate may be safely used the total daily ration. as a component of animal feed as an (c) To assure safe use of the additive, added source of choline to supplement the label and labeling of the additive the diets of poultry, ruminants, and and that of any feed additive supple- swine in accordance with good feeding ment, feed additive concentrate, feed practice. additive premix, or complete feed prepared therefrom shall contain, in addi- § 573.310 Crambe meal, heat toasted. tion to other information required by (a) The additive is the seed meal of the act, the following: Crambe abyssinica obtained after the re- (1) The name of the additive. moval of oil from the seed and hull. (2) The maximum percentage of The oil may be removed by pre-press equivalent crude protein from the non- solvent extraction or by solvent ex- protein nitrogen. traction alone. The resulting seed meal (3) If the feed additive premix, feed is heat toasted. additive concentrate, or feed additive (b) The additive conforms to the fol- supplement contains more than 2 per- lowing percent-by-weight specifica- cent equivalent crude protein from tions: moisture, not more than 11 per- diammonium phosphate, adequate di- cent; oil, not more than 4 percent; rections for use and a prominent state- crude protein, not less than 24 percent; ment, ‘‘Warning—This feed should be crude fiber, not more than 26 percent; used only in accordance with directions glucosinolate calculated as epi- furnished on the label.’’ progoitrin, not more than 4 percent; goitrin, not more than 0.1 percent; § 573.340 Diatomaceous earth. nitrile calculated as 1-cyano-2-hy- (a) Identity. The additive consists of droxy-3-butene, not more than 1.4 per- siliceous skeletal material derived cent. At least 50 percent of the nitro- from various species of diatoms. gen shall be soluble in 0.5 M sodium (b) Specifications. The additive shall chloride. Myrosinase enzyme activity conform to the following specifica- shall be absent. tions: (c) The additive is used or intended Lead, not more than 15 parts per million. for use in the feed of feedlot cattle as Arsenic (as As), not more than 20 parts per a source of protein in an amount not to million exceed 4.2 percent of the total ration. Fluorine, not more than 600 parts per million. [46 FR 30082, June 5, 1981] (c) Uses. It is used or intended for use § 573.320 Diammonium phosphate. as an inert carrier or anticaking agent The food additive diammonium phos- in animal feeds in an amount not to ex- phate may be safely used in ruminant ceed 2 percent by weight of the total feed in accordance with the following ration. prescribed conditions: (a) The food additive is the product § 573.360 Disodium EDTA. resulting from the neutralization of The food additive disodium EDTA feeding-phosphoric-acid or (disodium ethylenediaminetetraace- defluorinated wet-process phosphoric tate) may be safely used in animal

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feeds, in accordance with the following oxidative destruction of carotene, prescribed conditions: xanthophylls, and vitamins A and E.’’ (a) The food additive contains a minimum of 99 percent disodium ethylene- § 573.400 Ethoxyquin in certain dehy- diaminetetraacetate dihydrate drated forage crops. (C10H14O8N2Na2 ·2H2O). Ethoxyquin (1,2-dihydro-6-ethoxy- (b) It is used to solubilize trace min- 2,2,4-trimethylquinoline) may be safely erals in aqueous solutions, which are used in the dehydrated forage crops then added to animal feeds. listed in paragraph (a) of this section (c) It is used or intended for use in an when incorporated therein in accord- amount not to exceed 240 parts per mil- ance with the conditions prescribed in lion of the additive in finished feed. this section: (d) To assure safe use of the additive (a) It may be added to dehydrated the label and labeling shall bear: forage prepared from: (1) The name of the additive; and Alfalfa ...... Medicago sativa. (2) Adequate mixing directions to en- Barley ...... Hordeum vulgare. sure that the chelated trace-mineral Clovers: mix is uniformly blended throughout Alsike clover ...... Trifolium hybridum. the feed. Crimson clover ...... Trifolium incarnatum. Red clover ...... Trifolium pratense. § 573.380 Ethoxyquin in animal feeds. White clover (including La- Trifolium repens. dino). Ethoxyquin (1,2-dihydro-6-ethoxy- White sweetclover ...... Melilotus alba. 2,2,4-trimethylquinoline) may be safely Yellow sweetclover ...... Melilotus officinalis. used in animal feeds, when incor- Coastal Bermudagrass ...... Cynodon dactylon. porated therein in accordance with the Corn ...... Zea mays. Fescue ...... Festuca sp. following prescribed conditions. Oats ...... Avena sativa. (a) It is intended for use only: (1) As Orchardgrass ...... Dactylis glomerata. a chemical preservative for retarding Reed canarygrass ...... Pharlaris arundinacea. oxidation of carotene, xanthophylls, Ryegrass (annual and peren- Elymus sp. and Lolium and vitamins A and E in animal feed nial). perenne. Sorghums ...... Sorghum vulgare vars, fete- and fish food and, (2) as an aid in pre- rita, shallu, kaoliang, venting the development of organic broomcorn. peroxides in canned pet food. Sudan grass ...... Sorghum vulgare sudanense. (b) The maximum quantity of the ad- Wheat ...... Triticum aestivum. ditive permitted to be used and to re- or any mixture of such forage crops, for main in or on the treated article shall use only as an animal feed. not exceed 150 parts per million. (c) To assure safe use of the additive, (b) Such additive is used only as a the label and labeling of the food addi- chemical preservative for the purpose tive container and that of any inter- of retarding oxidative destruction of mediate premixes prepared therefrom naturally occurring carotenes and vita- shall contain, in addition to other in- min E in the forage crops. formation required by the act: (c) It is added to the dehydrated for- (1) The name of the additive, age crops in an oil mixture containing ethoxyquin. only suitable animal or suitable vege- (2) A statement of the concentration table oil, prior to grinding and mixing. or strength contained therein. (d) The maximum quantity of the ad- (3) Adequate use directions to provide ditive permitted to be used and to re- for a finished article with the proper main in or on the dehydrated forage concentration of the additive as pro- crop shall not exceed 150 parts per mil- vided in paragraph (b) of this section, lion. whether or not intermediate premixes (e) To assure the safe use of the addi- are to be used. tive, the label of the market package (d) The label of any animal feed con- shall contain, in addition to other in- taining the additive shall, in addition formation required by the act: to the other information required by (1) The name of the additive as speci- the act, bear the statement fied in this section. ‘‘Ethoxyquin, a preservative’’ or (2) Directions for the incorporation of ‘‘Ethoxyquin added to retard the the additive in the forage crops, as

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specified in paragraph (c) of this sec- (b) Specifications. The product con- tion, with the directive that only suit- tains 35 to 55 percent crude protein and able animal or suitable vegetable oils not more than 42 percent equivalent are to be used in the oil mix. crude protein from nonprotein nitrogen (f) The label of any dehydrated forage sources. crops treated with the additive or the (c) Uses. The product is used as a label of an animal-feed supplement source of protein and nonprotein nitro- containing such treated forage crops, gen for cattle. shall, in addition to other information (d) Limitations. (1) Store in a closed required by the act, bear the following vented tank equipped for agitation. statements: Agitate 5 minutes before using. Do not (1) ‘‘Ethoxyquin, a preservative,’’ or store at temperature above 110 °F (43 ‘‘Ethoxyquin added to retard the °C). oxidative destruction of carotene and (2) The maximum level of use of fer- vitamin E.’’ mented ammoniated condensed whey (2) The statement ‘‘For use in animal and equivalent crude protein from all feed only.’’ other added forms of nonprotein nitrogen shall not exceed 30 percent of the § 573.420 Ethyl cellulose. dietary crude protein. The food additive ethyl cellulose may (3) The additive may be used as fol- be safely used in animal feed in accord- lows: ance with the following prescribed con- (i) Mixed with grain, roughage, or ditions: grain and roughage prior to feeding. (a) The food additive is a cellulose (ii) As a component of free-choice liquid feeds, used to supplement the diets ether containing ethoxy (OC2H5) groups attached by an ether linkage and con- of cattle fed other sources of nutrients, taining on an anhydrous basis not more fermented ammoniated condensed than 2.6 ethoxy groups per whey shall not exceed 80 percent of the anhydroglucose unit. free-choice liquid feed. (b) It is used or intended for use as a (e) Labeling. The label shall bear, in binder or filler in dry vitamin prepara- addition to other information required tions to be incorporated into animal by the act: feed. (1) The name of the additive. (2) The maximum percentage of § 573.440 Ethylene dichloride. equivalent crude protein from non- The food additive ethylene dichloride protein nitrogen. may be safely used in the manufacture (3) Adequate directions for use in ac- of animal feeds in accordance with the cordance with the provisions in para- following prescribed conditions: graph (d) of this section. (a) It is used as a solvent in the ex- [43 FR 33708, July 1, 1978, as amended at 46 traction processing of animal byprod- FR 49115, Oct. 6, 1981] ucts for use in animal feeds. (b) The maximum quantity of the ad- § 573.460 Formaldehyde. ditive permitted to remain in or on the The food additive formaldehyde may extracted byproducts shall not exceed be safely used in the manufacture of 300 parts per million. animal feeds in accordance with the (c) The extracted animal byproduct is following conditions: added as a source of protein to a total (a) The additive is used, or intended ration at levels consistent with good for use, to improve the handling char- feeding practices, but in no event at acteristics of fat by producing a dry, levels exceeding 13 percent of the total free-flowing product, as follows: ration. (1) For animal fat in combination with certain oilseed meals, as a compo- § 573.450 Fermented ammoniated con- nent of dry, nonpelletted feeds for beef densed whey. and nonlactating dairy cattle. (a) Identity. The product is produced (i) An aqueous blend of soybean and by the Lactobacillus bulgaricus fer- sunflower meals in a ratio of 3:1, re- mentation of whey with the addition of spectively, is mixed with animal fat ammonia. such that the oilseed meals and animal

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fat are in a ratio of 3:2. The feed ingre- rector of the Office of the Federal Reg- dients are those defined by the ‘‘Offi- ister approves this incorporation by cial Publication’’ of the Association of reference in accordance with 5 U.S.C. American Feed Control Officials, Inc., 552(a) and 1 CFR part 51. You may ob- 2003 ed., pp. 303, 308, and 309, which is tain copies from the Assistant Sec- incorporated by reference. The Direc- retary-Treasurer, Association of Amer- tor of the Office of the Federal Register ican Feed Control Officials Inc., P.O. approves this incorporation by ref- Box 478, Oxford, IN 47971, or you may erence in accordance with 5 U.S.C. examine a copy at the Division of 552(a) and 1 CFR part 51. You may ob- Dockets Management, Food and Drug tain copies from the Assistant Sec- Administration, 5630 Fishers lane, rm. retary-Treasurer, Association of Amer- 1061, Rockville, MD 20852, or at the Na- ican Feed Control Officials Inc., P.O. tional Archives and Records Adminis- Box 478, Oxford, IN 47971, or you may tration (NARA). For information on examine a copy at the Division of the availability of this material at Dockets Management, Food and Drug NARA, call 202–741–6030, or go to: http:// Administration, 5630 Fishers Lane, rm. www.archives.gov/federallregister/ 1061, Rockville, MD 20852, or at the Na- codeloflfederallregulations/ tional Archives and Records Adminis- ibrllocations.html. tration (NARA). For information on (ii) Formaldehyde (37 percent solu- the availability of this material at tion) is added to the mixture at a level NARA, call 202–741–6030, or go to: http:// of 2.7 percent of the dry matter weight www.archives.gov/federallregister/ basis of the oilseeds and/or meals and codeloflfederallregulations/ the vegetable oil. This mixture, upon ibrllocations.html. drying, contains not more than 0.5 per- (ii) Formaldehyde (37 percent solu- cent formaldehyde and not more than tion) is added to the mixture at a level 12 percent moisture. of 4 percent of the dry matter weight of (iii) To assure the safe use of the ad- the oilseed meals and animal fat. This ditive, in addition to the other infor- mixture, upon drying, contains not mation required by the act, the label more than 1 percent formaldehyde and and labeling of the dried mixture shall not more than 12 percent moisture. bear: (iii) To assure the safe use of the ad- (A) The name of the additive. ditive, in addition to the other infor- (B) The statement, ‘‘This supplement mation required by the Federal Food, is not to exceed 12.5% of the total ra- Drug, and Cosmetic Act (the act), the tion. Dietary calcium and magnesium label and labeling of the dried mixture levels should be considered when shall bear: supplementing the diet with fat.’’ (A) The name of the additive. (C) The minimum and maximum lev- (B) Adequate directions for use pro- els of crude fat must be guaranteed and viding that the feed as consumed does must be between -5 percent and +5 per- not contain more than 25 percent of the cent of the analyzed fat content for mixture. each batch. (2) For soybean and canola seeds and/ (b)(1) The food additive is formalde- or meals to which there may be added hyde (CAS No. 50–00–0; 37 percent aque- vegetable oil as a component of dry, ous solution). It is used at a rate of 5.4 nonpelleted feeds for beef and dairy pounds (2.5 kilograms) per ton of ani- cattle, including lactating dairy cattle. mal feed or feed ingredient. It is an (i) An aqueous blend of oilseed and/or antimicrobial agent used to maintain meals, with or without added vegetable complete animal feeds or feed ingredi- oil, in a ratio such that, on a dry mat- ents Salmonella negative for up to 21 ter basis, the final protein level will be days. 25 to 35 percent and the fat content will (2) To assure safe use of the additive, be 20 to 45 percent. The feed ingredi- in addition to the other information re- ents are those defined by the ‘‘Official quired by the Act, the label and label- Publication’’ of the Association of ing shall contain: American Feed Control Officials, Inc., (i) The name of the additive. 2003 ed., pp. 301, 307, 308, and 309, which (ii) A statement that formaldehyde is incorporated by reference. The Di- solution which has been stored below 40

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°F or allowed to freeze should not be § 573.500 Condensed, extracted glu- applied to complete animal feeds or tamic acid fermentation product. feed ingredients. Condensed, extracted glutamic acid (iii) Adequate directions for use in- fermentation product may be safely cluding a statement that formaldehyde should be uniformly sprayed on and used in animal feed under the following thoroughly mixed into the complete conditions: animal feeds or feed ingredients and (a) The additive is a concentrated that the complete animal feeds or feed mixture of the liquor remaining from ingredients so treated shall be labeled the extraction of glutamic acid, com- as containing formaldehyde. The label bined with the cells of Corynebacterium must prominently display the state- lilium used to produce the glutamic ment: ‘‘Treated with formaldehyde to acid. maintain feed Salmonella negative. Use (b) It is used or intended for use as within 21 days.’’ follows: (iv) The labeling for feed or feed in- (1) In poultry feed as a source of pro- gredients to which formaldehyde has tein in an amount not to exceed 5 per- been added under the provisions of cent of the total ration. paragraph (b)(1) of this section is re- (2) In cattle feed as a source of pro- quired to carry the following state- tein in an amount not to exceed 10 per- ment: ‘‘Treated with formaldehyde to cent of the feed. maintain feed Salmonella negative. Use (c) In order to assure safe use, the within 21 days.’’ (3) To assure safe use of the additive, label and labeling of the additive shall in addition to the other information re- bear, in addition to the other informa- quired by the Act, the label and label- tion required by the Act, the following: ing shall contain: (1) The name of the additive. (i) Appropriate warnings and safety (2) A statement of the concentration precautions concerning formaldehyde. of the additive contained in any mix- (ii) Statements identifying formalde- ture. hyde as a poison with potentials for ad- (3) Adequate directions for use. verse respiratory effects. (iii) Information about emergency § 573.520 Hemicellulose extract. aid in case of accidental inhalation. Hemicellulose extract may be safely (iv) Statements reflecting require- used in animal feed when incorporated ments of applicable sections of the therein in accordance with the fol- Superfund Amendments and Reauthor- lowing conditions: ization Act (SARA), and the Occupa- tional Safety and Health Administra- (a) The additive is produced from the tion’s (OSHA) human safety guidance aqueous extract obtained by the treat- regulations. ment of wood with water at elevated (v) Contact address and phone num- temperatures (325 degrees–535 degrees ber for reporting adverse reactions or F) and pressure (80 to 900 pounds per to request a copy of the Materials Safe- square inch) and contains primarily ty Data Sheet (MSDS). pentose and hexose sugars. [41 FR 38652, Sept. 10, 1976, as amended at 54 (b) The additive may be used in a liq- FR 18281, Apr. 28, 1989; 61 FR 15704, Apr. 9, uid or dry state with the liquid product 1996; 63 FR 53580, Oct. 6, 1998; 68 FR 65633, containing not less than 55 percent car- Nov. 21, 2003] bohydrate and the dry product containing not less than 84 percent carbo- § 573.480 Formic acid. hydrate. Formic acid may be safely used as a (c) The additive is used as a source of preservative in hay crop silage in an metabolizable energy in animal feed in amount not to exceed 2.25 percent of accordance with good manufacturing the silage on a dry weight basis or 0.45 and feeding practices. percent when direct-cut. The top foot of silage stored should not contain for- [41 FR 38652, Sept. 10, 1976, as amended at 43 mic acid and silage should not be fed to FR 11181, Mar. 17, 1978] livestock within 4 weeks of treatment.

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§ 573.530 Hydrogenated corn syrup. with the following prescribed conditions: (a) Identity. The product is produced by hydrogenation of corn syrup over a (a) The additive is the chemical nickel catalyst. green ferric ammonium citrate. (b) Specifications. The product con- (b) The additive is used or intended tains 70 percent hydrogenated corn for use as an anticaking agent in salt syrup and a maximum of 0.5 percent re- for animal consumption so that the ducing sugars. level of iron ammonium citrate does (c) Uses. The product is used as a hu- not exceed 25 parts per million (0.0025 mectant and plasticizer in preparation percent) in the finished salt. of soft-moist dog and cat foods. (c) To assure safe use of the additive (d) Limitations. The product is pref- the label or labeling of the additive erably stored in a closed, stainless shall bear, in addition to the other in- steel or aluminum container. The level formation required by the Act: of use of the product shall not exceed (1) The name of the additive. 15 percent of the total weight of the pet (2) Adequate directions to provide a food formulation. final product that complies with the (e) Labeling. The labeling shall bear, limitations prescribed in paragraph (b) in addition to other information re- of this section. quired by the Act: § 573.580 Iron-choline citrate complex. (1) The name of the additive. (2) Adequate directions for use in ac- Iron-choline citrate complex made by cordance with the provisions in para- reacting approximately equimolecular graph (d) of this section. quantities of ferric hydroxide, choline, and citric acid may be safely used as a [45 FR 22920, Apr. 4, 1980] source of iron in animal feed.

§ 573.540 Hydrolyzed leather meal. § 573.600 Lignin sulfonates. (a) Identity. Hydrolyzed leather meal Lignin sulfonates may be safely used is produced from leather scraps that in animal feeds in accordance with the are treated with steam for not less following prescribed conditions: than 33 minutes at a pressure of not (a) For the purpose of this section, less than 125 pounds per square inch. the food additive is either one, or a (b) Specifications. The additive shall combination of, the ammonium, cal- conform to the following percent-by- cium, magnesium, or sodium salts of weight specifications: the extract of spent sulfite liquor de- Moisture, not less than 5 percent nor more rived from the sulfite digestion of wood than 10 percent. or of abaca (Musa textilis) or of sisal Crude protein, not less than 60 percent. (Agave sisalana) in either a liquid form Crude fat, not less than 5 percent. (moisture not to exceed 50 percent by Crude fiber, not more than 6 percent. weight) or dry form (moisture not to Chromium, not more than 2.75 percent. exceed 6 percent by weight). (c) Use. It is used or intended for use (b) It is used or intended for use in an as a source of protein in swine feeds in amount calculated on a dry weight an amount not to exceed 1.0 percent by basis, as follows: weight of the finished feed. (1) As a pelleting aid in the liquid or (d) Labeling. The labels and labeling dry form in an amount not to exceed 4 shall bear, in addition to the other in- percent of the finished pellets. formation required by the Act: (2) As a binding aid in the liquid form (1) The name of the additive, in the flaking of feed grains in an hydrolyzed leather meal. amount not to exceed 4 percent of the (2) Adequate directions to provide flaked grain. finished feeds complying with para- (3) As a surfactant in molasses used graph (c) of this section. in feeds, as liquid lignin sulfonate, in an amount not to exceed 11 percent of § 573.560 Iron ammonium citrate. the molasses. Iron ammonium citrate may be safe- (4) As a source of metabolizable en- ly used in animal feed in accordance ergy, in the liquid or dry form, in an

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amount not to exceed 4 percent of the in accordance with the prescribed con- finished feed. ditions: (a) The food additive is manufactured § 573.620 Menadione by the reaction of refined sunflower oil dimethylpyrimidinol bisulfite. with methanol to produce fatty acid The food additive, menadione methyl esters, which then undergo con- dimethylpyrimidinol bisulfite, may be jugation to yield methyl esters of octa- safely used in accordance with the fol- decadienoic acid. The additive consists lowing conditions: of not less than 28 percent methyl ester (a) The additive is the 2-hydroxy-4,6- of cis-9, trans-11-octadecadienoic acid, dimethylpyrimidinol salt of menadione and not less than 28 percent methyl (C17H18O6N2S). ester of trans-10, cis-12-octadecadienoic (b) The additive is used or intended acid with the sum of the other methyl for use as a nutritional supplement for esters of octadecadienoic acid not to the prevention of vitamin K deficiency exceed 4 percent. The additive shall as follows: contain not less than 35 percent of (1) In chicken and turkey feed at a other fatty acid esters composed of level not to exceed 2 grams per ton of oleic acid, palmitic acid, stearic acid, complete feed. linoleic acid, and other associated acid (2) In the feed of growing and fin- esters. ishing swine at a level not to exceed 10 (b) The additive is used or intended grams per ton of feed. for use in the feed of growing and fin- (c) To assure safe use, the label and ishing swine as a source of fatty acids labeling of the additive shall bear ade- at levels not to exceed 0.6% in the fin- quate directions for use. ished feed. (c) The additive meets the following § 573.625 Menadione nicotinamide bi- specifications: sulfite. (1) Free methyl alcohol not to exceed The food additive may be safely used 0.015%. as follows: (2) Insoluble impurities not to exceed (a) The additive is 1,2,3,4-tetrahydro- 0.1%. 2-methyl-1,4-dioxo-2-naphthalene sul- (3) Moisture not to exceed 0.5%. fonic acid with 3-pyridine carboxylic (4) Unsaponifiable matter not to ex- acid amine (CAS No. 73581–79–0). ceed 1.0%. (b) The additive is used or intended (d) To assure safe use of the additive, for use as a nutritional supplement for in addition to the other information re- both the prevention of vitamin K defi- quired by the act: ciency and as a source of supplemental (1) The label and labeling of the addi- niacin as follows: tive and any feed premix shall bear the (1) In chicken and turkey feeds at a following: level not to exceed 2 grams per ton of (i) The name of the additive. complete feed. (ii) A statement to indicate that (2) In growing and finishing swine methyl esters of conjugated linoleic feeds at a level not to exceed 10 grams acid (cis-9, trans-11 and trans-10, cis-12 per ton of complete feed. octadecadienoic acids) must not be (c) To assure safe use, the label and added to vitamin or mineral premixes. labeling of the additive shall bear ade- (2) The label and labeling of the addi- quate directions for use. tive, any feed premix, or complete feed prepared therefrom shall bear adequate [64 FR 46840, Aug. 27, 1999] directions for use. § 573.637 Methyl esters of conjugated [73 FR 64198, Oct. 29, 2008] linoleic acid (cis-9, trans-11 and trans-10, cis-12-octadecadienoic § 573.640 Methyl esters of higher fatty acids). acids. The food additive, methyl esters of The food additive methyl esters of conjugated linoleic acid (cis-9, trans-11 higher fatty acids may be safely used and trans-10, cis-12 octadecadienoic in animal feeds in accordance with the acids), may be safely used in swine feed following prescribed conditions:

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(a) The food additive is manufactured available for inspectionat the National by reaction of methyl alcohol with Archives and Records Administration feed-grade fats or oils and consists of (NARA). For information on the avail- not less than 70 percent methyl esters ability of this material at NARA, call of the following straight-chain 202–741–6030, or go to: http:// monocarboxylic acids: Docosahexanoic www.archives.gov/federallregister/ acid, eicosapentanoic acid, linoleic codeloflfederallregulations/ acid, myristic acid, oleic acid, palmitic ibrllocations.html. ) The presence of acid, palmitoleic acid, and stearic acid, chick-edema factor shall be determined and lesser amounts of the associated by a comparison between the mean log acid esters. of the pericardial fluid volumes of a (b) The food additive meets the fol- test group and of a concurrent negative lowing specifications: control group. The significance of the (1) Free methyl alcohol not to exceed difference in pericardial fluid volumes 150 parts per million. between the test group and the nega- (2) Unsaponifiable matter not to ex- tive control group is determined by ceed 2 percent. calculating a ‘‘t’’ value according to (3) It is free of chick-edema factor or the formula: other factors toxic to chicks, as evi- xx− denced during the bioassay method for t = tc determining the chick-edema factor as 22+ prescribed in paragraph (b)(4)(ii) of this ()sntt//() sn cc section. where: (4) For the purposes of this section: x¯ t and x¯ c are the means of the logs of the (i) Unsaponifiable matter shall be de- pericardial fluid volumes of the test and termined by the method described in control groups, respectively; Section 28.081, ‘‘Unsaponifiable Residue nt and nc are the number of chicks in the re- (20)—Official Final Action’’ of the ‘‘Of- spective groups; 2 2 ficial Methods of Analysis of the Asso- st and sc are the variances of the test and ciation of Official Analytical Chem- control groups, respectively. ists,’’ 13th Ed., 1980, p. 451, which is in- The variances are calculated as follows: corporated by reference. Copies are nx()(∑−∑22 x) available from the AOAC INTER- s2 = NATIONAL, 481 North Frederick Ave., − suite 500, Gaithersburg, MD 20877, or nn( 1) available for inspection at the National where: Archives and Records Administration Sx is the sum of the logs of the pericardial (NARA). For information on the avail- fluid volumes; ability of this material at NARA, call Sx2 is the sum of the squares of the logs of 202–741–6030, or go to: http:// the pericardial fluid volumes for either the test t or control c group data. www.archives.gov/federallregister/ codeloflfederallregulations/ The test sample is judged to contain ibrllocations.html. chick-edema factor if the calculated (ii) The chick-edema factor bioassay ‘‘t’’ exceeds +1.3 and the mean log of method described under ‘‘26. Oils, Fats, the pericardial fluid volume obtained and Waxes’’ in the Journal of the Asso- from the negative control group multi- ciation of Official Agricultural Chemists, plied by 100 is less than 1.1461. Vol. 44, Page 146 (1961), or the method (iii) ‘‘Other factors toxic to chicks’’ described under ‘‘Chick-Edema Fac- referred to in paragraph (b)(3) of this tor—Bioassay Method (34)—Official section shall be determined during the Final Action’’ in §§ 28.113–28.117, ‘‘Offi- course of the bioassay test described in cial Methods of Analysis of the Asso- paragraph (b)(4)(ii) of this section, on ciation of Official Analytical Chem- the basis of chick deaths or other ab- ists,’’ 12th Ed., 1975, pp. 509–511, which normalities not attributable to chick- is incorporated by reference, shall be edema factor or to the experimental employed. (Copies of the methods are conditions of the test. available from the AOAC INTER- (c) It is used or intended for use as a NATIONAL, 481 North Frederick Ave., supplementary source of fat for animal suite 500, Gaithersburg, MD 20877, or feed.

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(d) To assure safe use of the additive, (5) For the removal of water from in addition to the other information re- substances intended as ingredients of quired by the act: animal feed. (1) The label and labeling of the addi- (c) The quantity of mineral oil used tive, and any feed additive supplement, in animal feed shall not exceed 3.0 per- feed additive concentrate, feed additive cent in mineral supplements, nor shall premix, or complete feed prepared it exceed 0.06 percent of the total ra- therefrom shall bear: tion when present in feed or feed con- (i) The name of the additive. centrates. (ii) The designation ‘‘feed grade’’ in [41 FR 38652, Sept. 10, 1976, as amended at 47 juxtaposition with the name and equal- FR 41106, Sept. 17, 1982] ly as prominent. (2) The label or labeling of the addi- § 573.685 Natamycin. tive and any feed additive supplement, The food additive natamycin (CAS feed additive concentrate, feed additive No. 7681–93–8) may be safely used in premix, or complete feed prepared broiler chicken feeds in accordance therefrom shall bear adequate direc- with the following specifications: tions for use. (a) The additive is a stereoisomer of [41 FR 38652, Sept. 10, 1976, as amended at 47 22-[(3-amino-3,6,dideoxy-b-D- FR 9397, Mar. 5, 1982; 54 FR 18281, Apr. 28, mannopyranosyl)oxy]-1,3,26- 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, trihydroxy-12-methyl-10-oxo-6,11,28- Nov. 8, 2005] trioxatricyclo[22.3.1.05, 7] octacosa- 8,14,16,18,20-pentaene-25-carboxylic acid § 573.660 Methyl glucoside-coconut oil with the empirical formula C33H47NO13. ester. (b) The additive shall conform to Methyl glucoside-coconut oil ester U.S.P. specifications. may be safely used in accordance with (c) The additive (as part of a premix the following conditions: composed of calcium carbonate, (a) The additive meets the specifica- natamycin, and lactose) is used for re- tions prescribed in § 172.816 of this tarding the growth of Aspergillus chapter. parasiticus in broiler chicken feeds for (b) It is used as a surfactant in mo- up to 14 days after the addition of lasses intended for use in animal feed natamycin. at a level not to exceed 320 parts per (d) Each pound (454 grams (g)) of the million. premix shall contain 434 (g) of calcium carbonate, 10 g of natamycin activity, § 573.680 Mineral oil. and 10 g of lactose. The premix shall be Mineral oil may be safely used in ani- mixed into broiler chicken feed at the mal feed, subject to the provisions of rate of 1 pound (0.454 kilograms (kg)) this section. per ton (908 kg) of feed to provide (a) Mineral oil, for the purpose of this natamycin at a level of 11 parts per section, is that complying with the def- million (ppm). The premix shall be inition and specifications contained in thoroughly mixed into the dry compo- § 172.878 (a) and (b) or in § 178.3620(b)(1) nents of the broiler chicken feed before (i) and (ii) of this chapter. adding the liquid components. Broiler (b) It is used in animal feeds for the feeds to which the natamycin premix is following purposes: added shall be used within 4 weeks of (1) To reduce dustiness of feeds or addition of the premix. mineral supplements. (e) To assure the safe use of the addi- (2) To serve as a lubricant in the tive, the label or labeling of the addi- preparation of pellets, cubes, or blocks tive shall bear, in addition to other in- and to improve resistance to moisture formation required by the Federal of such pellets, cubes, or blocks. Food, Drug, and Cosmetic Act, the fol- (3) To prevent the segregation of lowing: trace minerals in mineralized salt. (1) The name and CAS number of the (4) To serve as a diluent carrier in additive, and its purpose. the manufacture of feed grade biuret in (2) A listing of ingredients consisting accordance with good manufacturing of calcium carbonate, the additive, and practice. lactose and their proportions in the

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premix as prescribed under paragraph Ultraviolet absorbance per centimeter (d) of this section. path length: (3) Adequate directions for use to en- Millimicrons Maximum sure a broiler chicken feed that is in compliance with the limitations pre- 280 to 289 ...... 0.25 290 to 299 ...... 20 scribed in paragraph (d) of this section. 300 to 359 ...... 14 (4) An appropriate cautionary state- 360 to 400 ...... 04 ment: ‘‘Caution: Store in a tightly- closed, light-resistant container in a (c) It is used in animal feed for the cool, dry place.’’ following purposes: (5) An expiration date of 1 year from (1) To reduce dustiness of feeds or the date of manufacture. mineral supplements. (6) A contact address and telephone (2) To serve as a lubricant in the number for reporting adverse reactions preparation of pellets, cubes, or blocks, experienced by users, or to request a and to improve resistance to moisture copy of the Material Safety Data Sheet of such pellets, cubes, or blocks. for natamycin. (d) The quantity of petrolatum present in animal feeds from the uses [69 FR 19321, Apr. 13, 2004] specified in paragraph (c) of this section shall not exceed 3 percent in min- § 573.700 Sodium nitrite. eral supplements nor shall it exceed Sodium nitrite may be safely used in 0.06 percent of the total ration when canned pet food containing meat and present in feed or feed concentrates. fish in accordance with the following (e) When used in combination with prescribed conditions: technical white mineral oil for the uses (a) It is used or intended for use described in paragraph (c) of this sec- alone as a preservative and color fixa- tion, the total quantity of combined tive in canned pet food containing fish, petrolatum and technical white min- meat, and fish and meat byproducts so eral oil shall not exceed the limits pre- that the level of sodium nitrite does scribed in paragraph (d) of this section. not exceed 20 parts per million. (f) Petrolatum may contain any anti- (b) To assure safe use of the additive, oxidant permitted in food by regula- in addition to the other information re- tions issued in accordance with section quired by the act: 409 of the act, in an amount not greater (1) The label of the additive shall than that required to produce its in- bear: tended effect. (i) The name of the additive. § 573.740 Odorless light petroleum hy- (ii) A statement of the concentration drocarbons. of the additive in any mixture. Odorless light petroleum hydro- (2) The label or labeling shall bear carbons complying with § 172.884(a) and adequate directions to provide a final (b) of this chapter may be safely used product that complies with the limita- in an amount not in excess of that re- tions prescribed in paragraph (a) of this quired as a component of insecticide section. formulations used in compliance with regulations issued in this part. § 573.720 Petrolatum. Petrolatum may be safely used in or § 573.750 Pichia pastoris dried yeast. on animal feed, subject to the fol- (a) Identity. The food additive Pichia lowing prescribed conditions: pastoris dried yeast may be used in feed (a) Petrolatum complies with the formulations of broiler chickens as a specifications set forth in the U.S. source of protein not to exceed 10 per- Pharmacopeia XVI for white petro- cent by weight of the total formula- latum or in The National Formulary tion. XII for yellow petrolatum. (b) Specifications. The additive shall (b) Petrolatum meets the following conform to the following percent-by- ultraviolet absorbance limits when weight specifications: subjected to the analytical procedure (1) Crude protein, not less than 60 described in § 172.886(b) of this chapter. percent.

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(2) Crude fat, not less than 2 percent. the specifications in item 2.1 of (3) Crude fiber, not more than 2 per- § 177.1520(c) of this chapter. cent. (2) The polyethylene is designed in a (4) Ash, not more than 13 percent. pellet form in a configuration pre- (5) Moisture, not more than 6 per- senting maximum angular surface hav- cent. ing the following dimensions in centi- (c) Use. To ensure safe use, the label- meters: ing of the additive and any feed addi- 0.9 ±0.1 × 0.8 ±0.1 × 1.2 ±0.1 tive supplement, concentrate, or pre- (c) Use. It is used as a replacement mix prepared therefrom shall bear, in for roughage in feedlot rations for fin- addition to other required information, ishing slaughter cattle. the name of the additive, directions for (d) Labeling. The labels and labeling use to provide not more than 10 percent shall bear in addition to the other in- by weight of the total ration, and the formation required by the Act: statement ‘‘Caution: Not to be used in (1) The name of the additive ‘‘poly- layers or other poultry intended for ethylene roughage replacement.’’ breeding.’’ (2) Adequate directions for use which [58 FR 59170, Nov. 8, 1993] shall provide for the administration of one-half pound of polyethylene pellets § 573.760 Poloxalene. per head per day for 6 successive days. The food additive poloxalene may be All natural roughage should be re- safely used in accordance with the fol- moved for a minimum of 12 hours prior lowing prescribed conditions: to administration of polyethylene (a) The additive consists of polyoxy- roughage replacement. Roughage re- propylene-polyoxyethylene glycol non- placement must be adequately mixed ionic block polymer meeting the fol- in the ration for uniform distribution. lowing specifications: [41 FR 38652, Sept. 10, 1976, as amended at 54 (1) Molecular weight range: 2,850– FR 18282, Apr. 28, 1989] 3,150. (2) Hydroxyl number: 35.7–39.4. § 573.800 Polyethylene glycol (400) mono- and dioleate. (3) Cloud point (10 percent solution): 42 °C–46 °C. (a) The food additive polyethylene (4) Structural formula: glycol (400) mono- and dioleate meets the following specifications: Saponi- ⎯⎯ HO(CH2211 CH O)( -13) fication number, 80–88; acid number, 5.0 ⎯⎯ ⎯⎯ CHCH2 O(32-36) ( CH2211 CH O)( -13) H maximum; and average molecular weight range, 640–680. CH (b) It is used as a processing aid in 3 the production of animal feeds when (b) In feed as a surfactant for the present as a result of its addition to flaking of feed grains when added to molasses in an amount not to exceed liquid grain conditioner in an amount 250 parts per million of the molasses. not to exceed 1.0 percent of the conditioner. The conditioner is added to the § 573.820 Polyoxyethylene glycol (400) feed at a rate of 1 quart per ton of feed. mono- and dioleates. (c) The label and labeling shall bear, The food additive polyoxyethylene in addition to the other information re- glycol (400) mono- and dioleates may be quired by the Act: safely used as an emulsifier in calf- (1) The name of the additive. milk replacer formulations. (2) Adequate directions and warnings for use. § 573.840 Polysorbate 60. The food additive polysorbate 60 § 573.780 Polyethylene. (polyoxyethylene (20) sorbitan mono- (a) Identity. Polyethylene consists of stearate) may be safely used in animal basic polymers manufactured by the feeds in accordance with the following catalytic polymerization of ethylene. prescribed conditions: (b) Specifications. (1) For the purposes (a) It is used alone or in combination of this section, polyethylene shall meet with sorbitan monostearate as an

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emulsifier in mineral premixes and die- nine and lysine by weight. The coated tary supplements for animal feeds. methionine and lysine must be estab- (b) It is used as an emulsifier in milk- lished through in vitro tests to be at replacer formulations for calves. least 90 percent rumen-stable, of which at least 90 percent is subsequently dis- § 573.860 Polysorbate 80. persible under abomasal conditions. The food additive polysorbate 80 (c) Label and labeling. To ensure safe (polyoxyethylene (20) sorbitan use of the additive, the label and label- monooleate) may be safely used as an ing of the additive and of any feed addi- emulsifier in milk-replacer formula- tive supplement, feed additive con- tions for calves. centrate, feed additive premix, or liquid feed supplement prepared there- § 573.870 Poly(2-vinylpyridine-co-sty- from, shall bear, in addition to the rene). other information required by the Fed- The food additive poly(2- eral Food, Drug, and Cosmetic Act, the vinylpyridine-co-styrene) may be safe- following: ly used as nutrient protectant in feed (1) The name of the additive. for beef cattle and dairy cattle and re- (2) A statement of the concentration placement dairy heifers when used in of poly(2-vinylpyridine-co-styrene) in accordance with the following condi- any product or mixture. tions: (3) Adequate directions for the use of (a) The additive meets the following the rumen-stable, abomasum-dispers- specifications: ible nutrient(s) products. (4) The following statement: ‘‘Warn- Component/property Limitation ing: Maximum use of poly(2- Inherent viscosity ...... 1.0-1.6 deciliter per gram.1 vinylpyridine-co-styrene) from all Styrene moiety ...... 40 percent maximum. sources is not to exceed 5.1 grams per 2-Vinylpyridine moiety...... 90 percent maximum. head per day.’’ Residual styrene ...... 200 parts per billion maximum. [57 FR 7875, Mar. 5, 1992, as amended at 57 FR Residual 2-vinylstyrene ...... 200 parts per billion max- 24187, June 8, 1992; 61 FR 11547, Mar. 21, 1996; imum. 70 FR 13100, Mar. 18, 2005] Heavy metals such as lead .... 10 parts per million maximum. Arsenic ...... 3 parts per million maximum. § 573.880 Normal propyl alcohol. 1 Inherent viscosity of a 0.25 percent (weight/volume) solu- Normal propyl alcohol may be safely tion in dimethylformamide. used in feeds and feed supplements for (b) The additive is used in the manu- cattle as a source of metabolizable en- facture of rumen-stable, abomasum- ergy. It is incorporated in the feed or dispersible nutrient(s) for beef cattle feed supplement in an amount which and dairy cattle and replacement dairy provides not more than 54.5 grams of heifers such that the maximum use of the additive per head per day. the additive from all sources does not exceed 5.1 grams per head per day. The § 573.900 Pyrophyllite. additive may be used to protect the fol- Pyrophyllite (aluminum silicate lowing nutrients: monohydrate) may be safely used as (1) Methionine. The resulting product the sole anticaking aid, blending agent, must contain a maximum of 10 percent pelleting aid, or carrier in animal feed poly(2-vinylpyridine-co-styrene) by when incorporated therein in an weight and a minimum of 55 percent amount not to exceed 2 percent in com- methionine by weight. The coated me- plete animal feed. thionine must be established through in vitro tests to be at least 90 percent § 573.914 Salts of volatile fatty acids. rumen-stable, of which at least 90 per- (a) Identity. The food additive is a cent is subsequently dispersible under blend containing the ammonium or abomasal conditions. calcium salt of isobutyric acid and the (2) Methionine and lysine. The result- ammonium or calcium salts of a mixing product must contain a maximum ture of 5-carbon acids—isovaleric, 2- of 10 percent poly(2-vinylpyridine-co- methylbutyric, and n-valeric. styrene) by weight and a minimum of a (b) Specifications. The additive con- combined total of 55 percent methio- tains ammonium or calcium salts of

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volatile fatty acids and shall conform tion of such rule issued after enact- to the following specifications: ment of the 1994 Act; unless the Com- (1) Ammonium salts: missioner of Food and Drugs makes a determination that: Components Amount (1) Selenium additives are not essen- Ammonium salts of mixed 5-car- 48 to 54 percent. tial at levels authorized in the absence bon acids (as identified in para- of such final rule, to maintain animal graph (a) of this section). Ammonium salt of isobutyric acid 22 to 26 percent. nutrition and protect animal health; Water ...... 28 percent maximum. (2) selenium at such levels is not safe Ammonia ...... 0.3 percent maximum. to the animals consuming the additive; Arsenic ...... 3 parts per million maximum. (3) selenium at such levels is not safe Heavy metals such as lead ...... 10 parts per million max- to individuals consuming edible por- imum. tions of animals that receive the additive; (2) Calcium salts: (4) selenium at such levels does not Components Amount achieve its intended effect of pro- moting normal growth and reproduc- Calcium salts of mixed 5-carbon 58 to 72 percent. acids (as identified in paragraph tion of livestock and poultry; and (a) of this section). (5) the manufacture and use of sele- Calcium salt of isobutyric acid ...... 26 to 34 percent. nium at such levels cannot reasonably Calcium hydroxide ...... 3 percent maximum. Water ...... 14 percent maximum. be controlled by adherence to current Arsenic ...... 3 parts per million max- good manufacturing practice require- imum. ments. Heavy metals such as lead ...... 10 parts per million maximum. (6) Paragraphs (b) through (g) of this section provide the currently accept- (c) Use. The additive is used or in- able levels of selenium supplemen- tended for use as a source of energy in tation. dairy cattle feed. (b) The food additive selenium is a (d) Labeling. The label and labeling of nutrient administered in animal feed the additive in any feed, feed supple- as sodium selenite or sodium selenate ment, feed concentrate, feed premix, or or in a controlled-release sodium sele- liquid feed supplement prepared there- nite bolus, as provided in paragraphs (f) from shall bear, in addition to other in- and (g) of this section, or as selenium formation required by the act, the fol- yeast, as provided in paragraph (h) of lowing: this section. (1) The name of the additive. (c) It is added to feed as follows: (2) Adequate directions for use, in- (1) In complete feed for chickens, cluding statements expressing max- swine, turkeys, sheep, cattle, and imum use levels. For ammonium salts ducks at a level not to exceed 0.3 part of volatile fatty acids, the statements: per million. ‘‘Not to exceed 160 grams per head per (2) In feed supplements for limit feed- day thoroughly mixed in dairy cattle ing as follows: feed as a source of energy.’’ For cal- (i) Sheep: At a level not to exceed an cium salts of volatile fatty acids, the intake of 0.7 milligram per head per statement: ‘‘Not to exceed 135 grams day. per head per day thoroughly mixed in (ii) Beef cattle: At a level not to ex- dairy cattle feed as a source of en- ceed an intake of 3 milligrams per head ergy.’’ per day. [49 FR 45125, Nov. 15, 1984; 50 FR 8606, Mar. 4, (3) In salt-mineral mixtures for free- 1985, as amended at 70 FR 13100, Mar. 18, 2005] choice feeding as follows: (i) Sheep: Up to 90 parts per million in § 573.920 Selenium. a mixture for free-choice feeding at a (a) Public Law 103–354 enacted Octo- rate not to exceed an intake of 0.7 mil- ber 13, 1994 (the 1994 Act), states that ligram per head per day. FDA shall not implement or enforce (ii) Beef cattle: Up to 120 parts per the final rule issued on September 13, million in a mixture for free-choice 1993 (58 FR 47962), in which FDA stayed feeding at a rate not to exceed an in- the 1987 amendments and any modifica- take of 3 milligrams per head per day.

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(d) The additive shall be incorporated cane molasses and selenium salts in a into feed as follows: manner which minimizes the detri- (1) It shall be incorporated into each mental effects of selenium salts on the ton of complete feed by adding no less growth rate of the yeast and allows for than 1 pound of a premix containing no optimal incorporation of inorganic se- more than 272.4 milligrams of added selenium into cellular organic material. lenium per pound. Residual inorganic selenium is elimi- (2) It shall be incorporated into each nated in a rigorous washing process ton of salt-mineral mixture for sheep and must not exceed 2 percent of the or beef cattle from a premix containing total selenium content in the final se- no more than 4.5 grams of added sele- lenium yeast product. nium per pound. (1) Selenium, as selenium yeast, is (e) The premix manufacturer shall added to feed as follows: follow good manufacturing practices in (i) In complete feed for chickens, tur- the production of selenium premixes. keys, swine, beef cattle, and dairy cat- Inventory, production, and distribution tle at a level not to exceed 0.3 part per records must provide a complete and million. accurate history of product production. (ii) In feed supplements for limit Production controls must assure prod- feeding for beef cattle at a level not to ucts to be what they are purported and exceed an intake of 3 milligrams per labeled. Production controls shall in- head per day. clude analysis sufficient to adequately (iii) In salt-mineral mixtures for free- monitor quality. choice feeding for beef cattle up to 120 (f) The label or labeling of any sele- parts per million in a mixture for free- nium premix shall bear adequate direc- choice feeding at a rate not to exceed tions and cautions for use including an intake of 3 milligrams per head per this statement: ‘‘Caution: Follow label day. directions. The addition to feed of (2) Guaranteed organic selenium con- higher levels of this premix containing tent from selenium yeast must be de- selenium is not permitted.’’ clared on the selenium yeast product (g) The additive is orally adminis- label. tered to beef and dairy cattle as an os- (3) The additive, as selenium yeast, motically controlled, constant release shall be incorporated into feed as fol- bolus containing sodium selenite. Each lows: (i) It shall be incorporated into each bolus contains 360 milligrams of sele- ton of complete feed by adding no less nium as sodium selenite, and delivers 3 than 1 pound of a premix containing no milligrams of selenium per day for 120 more than 272.4 milligrams of added se- days. To ensure safe use of the addi- lenium per pound. tive: (ii) It shall be incorporated into each (1) The osmotically controlled, con- ton of salt-mineral mixture for beef stant release bolus is for use only in cattle from a premix containing no beef and dairy cattle more than 3 more than 4.5 grams of added selenium months of age or over 200 pounds body per pound. weight. (4) Usage of this additive must con- (2) Only one bolus containing 360 mil- form to the requirements of paragraphs ligrams of selenium as sodium selenite (e) and (f) of this section. is administered orally to each animal in 120 days. [52 FR 10888, Apr. 6, 1987; 52 FR 21001, June 4, (3) The labeling shall bear the fol- 1987, as amended at 54 FR 14215, Apr. 10, 1989; lowing: ‘‘This bolus delivers the max- 54 FR 15874, Apr. 19, 1989; 60 FR 53703, Oct. 17, imum daily allowable amount of sele- 1995; 65 FR 35824, June 6, 2000; 65 FR 53167, Sept. 1, 2000; 67 FR 46851, July 17, 2002; 68 FR nium and shall be the sole source of 52340, Sept. 3, 2003; 72 FR 39561, July 19, 2007] supplementation. Do not use in areas containing excess selenium. Do not EFFECTIVE DATE NOTE: At 58 FR 47973, rebolus within 4 months.’’ Sept. 13, 1993, the amendments to § 573.920 that were published at 52 FR 10887, Apr. 6, (h) Selenium yeast is a dried, non- 1987; 52 FR 21001, June 4, 1987; and 54 FR viable yeast (Saccharomyces cerevisiae) 14214, Apr. 10, 1989 were stayed until further cultivated in a fed-batch fermentation notice. At 59 FR 45973, Sept. 6, 1994, the stay which provides incremental amounts of was confirmed.

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§ 573.940 Silicon dioxide. (a) The additive is a magnesium-aluminum-iron silicate conforming to one The food additive silicon dioxide may of the following: be safely used in animal feed in accordance with the following conditions: (1)(i) Verxite granules: The additive (a) The food additive is manufactured contains a minimum of 98 percent of by vapor phase hydrolysis or by other hydrobiotite; it is thermally expanded means whereby the particle size is such and has a bulk density of from 5 to 9 as to accomplish the intended effect. pounds per cubic foot. (b) It is used or intended for use in (ii) It is used or intended for use: feed components as an anticaking (a) In poultry feed at a level not to agent, and/or grinding aid, as follows: exceed 5 percent of the weight of the finished feed as a nonnutritive bulking Limitations agent for restricting calorie intake in Feed component (percent) pullet replacement feeds. BHT (butylated hydroxytoluene) ...... 2 (b) As an anticaking or blending Methionine hydroxy analog and its calcium salts 1 agent, pelleting aid, or nonnutritive Piperazine, piperazine salts ...... 0.8 Sodium propionate ...... 1 carrier for the incorporation of nutri- Urea ...... 1 ents in poultry, swine, dog, or rumi- Vitamins ...... 3 nant feeds, in an amount not to exceed that necessary to accomplish its in- (c) It is used in feed as an anticaking tended effect and in no case to exceed agent in an amount not to exceed that 1.5 percent of the dog feed or 5 percent reasonably required to accomplish its of the final feed for other animals. intended effect and in no case in an (2)(i) Verxite flakes: The additive amount to exceed 2 percent by weight contains a minimum of 98 percent of of the finished feed. hydrobiotite; it has a bulk density of from 20 to 30 pounds per cubic foot. § 573.960 Sorbitan monostearate. (ii) It is used or intended for use as The food additive sorbitan monostea- an anticaking or blending agent in ru- rate may be safely used alone or in minant feeds in an amount not to ex- combination with polysorbate 60 as an ceed that necessary to accomplish its emulsifier in mineral premixes and die- intended effect and in no case to exceed tary supplements for animal feeds. 1 percent by weight of the final feed for ruminants. § 573.980 Taurine. (3)(i) Verxite grits: The additive con- The food additive taurine (2-amino- tains a minimum of 80 percent of ethanesulfonic acid) may be safely used hydrobiotite; it has a bulk density of in feed in accordance with the fol- from 40 to 50 pounds per cubic foot. lowing prescribed conditions: (ii) It is used or intended for use as a (a) It is used as a nutritional supple- partial roughage replacement in rumi- ment in the feed of growing chickens. nant feeds in an amount not to exceed (b) It is added to complete feeds so that necessary to accomplish its in- that the total taurine content does not tended effect and in no case to exceed exceed 0.054 percent of the feed. 1 percent by weight of the final feed. (c) To assure safe use of the additive, (b) To assure safe use of the additive, the label and labeling shall bear in ad- the label of any feed additive supple- dition to the other information re- ment, feed additive concentrate, feed quired by the Act: additive premix, or complete feed pre- (1) The name of the additive. pared therefrom shall bear, in addition (2) The quantity of the additive con- to the other information required by tained therein. the Act, the name of the additive (3) Adequate directions for use. (verxite granules, verxite flakes, or verxite grits), adequate directions for § 573.1000 Verxite. use, and, when the additive is present The food additive verxite may be in excess of 1 percent, a statement of safely used in animal feed in accord- the quantity of the additive contained ance with the following prescribed con- therein and the term ‘‘nonnutritive’’ in ditions: juxtaposition therewith.

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§ 573.1010 Xanthan gum. AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. The food additive xanthan gum may be safely used in animal feed as fol- Subpart A—General Provisions lows: (a) The food additive is xanthan gum § 579.12 Incorporation of regulations as defined in § 172.695 of this chapter in part 179. and meets all of the specifications Regulations providing for irradiation thereof. in the production, processing, and han- (b) It is used or intended for use as a dling of food in part 179 of this chapter stabilizer, emulsifier, thickener, sus- are incorporated in subchapter E as ap- pending agent, or bodying agent in ani- plicable to use in the production, proc- mal feed as follows: essing, handling, and labeling of ani- (1) In calf milk replacers at a max- mal feed and pet food, except where imum use level of 0.1 percent, as fed. specifically provided for in this part. (2) In liquid feed supplements for ruminant animals at a maximum use [51 FR 5993, Feb. 19, 1986] level of 0.25 percent (5 pounds per ton). (c) To assure safe use of the additive: Subpart B—Radiation and (1) The label of its container shall Radiation Sources bear, in addition to other information required by the act, the name of the § 579.22 Ionizing radiation for treat- additive. ment of animal diets. (2) The label or labeling of the addi- Ionizing radiation for treatment of tive container shall bear adequate di- complete diets for animals may be rections for use. safely used under the following condi- [49 FR 44630, Nov. 8, 1984] tions: (a) Energy sources. Ionizing radiation § 573.1020 Yellow prussiate of soda. is limited to: Yellow prussiate of soda (sodium fer- (1) Gamma rays for sealed units of the radionuclides cobalt-60 or cesium- rocyanide decahydrate: Na4Fe(Cn)6°- 137. 10H2O) may be safely used as an anticaking agent in salt for animal (2) Electrons generated from machine consumption at a level not to exceed 13 sources at energy levels not to exceed parts per million. The additive con- 10 million electron volts. tains a minimum of 99.0 percent by (b) Uses. (1) The ionizing radiation is weight of sodium ferrocyanide decahy- used or intended for use in single treat- drate. ment as follows:

[41 FR 38657, Sept. 10, 1976; 41 FR 48100, Nov. Food for irradiation Limitations Use 2, 1976] Bagged complete Absorbed dose: Microbial disinfec- diets, packaged Not to exceed tion, control or PART 579—IRRADIATION IN THE feeds, feed ingre- 50 kiloGrays. elimination PRODUCTION, PROCESSING, dients, bulk feeds, Feeds and animal treats and feed ingredi- AND HANDLING OF ANIMAL chews. ents treated FEED AND PET FOOD by irradiation should be for- mulated to Subpart A—General Provisions account for nutritional Sec. loss. 579.12 Incorporation of regulations in part 179. (2) If an irradiated feed ingredient is Subpart B—Radiation and Radiation less than 5 percent of the final product, Sources the final product can be irradiated without being considered to be re-irra- 579.22 Ionizing radiation for treatment of diated. animal diets. 579.40 Ionizing radiation for the treatment [51 FR 5993, Feb 19, 1986; 51 FR 8315, Mar. 11, of poultry feed and poultry feed ingredi- 1986, as amended at 58 FR 18148, Apr. 8, 1993; ents. 66 FR 18540, Apr. 10, 2001]

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