Tolerances for residues of new animal drugs in food (21 CFR 556.1-556.770)

389 Food and Drug Administration, HHS Pt. 556 following the procedures in § 530.25. The prohibited extralabel drug use will be codified in § 530.41. Subpart E—Safe Levels for Extralabel Use of Drugs in Ani mals and Drugs Prohibited From Extralabel Use in Ani mals § 530.40 Safe levels and availability of analytical methods. (a) In accordance with § 530.22, the following safe levels for extralabel use of an approved animal drug or human drug have been established: [Reserved] (b) In accordance with § 530.22, the following analytical methods have been accepted by FDA: [Reserved] § 530.41 Drugs prohibited for extralabel use in animals. (a) The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in food-producing animals. (1) Chloramphenicol; (2) Clenbuterol; (3) Diethylstilbestrol (DES); (4) Dimetridazole; (5) Ipronidazole; (6) Other nitroimidazoles; (7) Furazolidone. (8) Nitrofurazone. (9) Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine); (10) Fluoroquinolones; and (11) Glycopeptides. (12) Phenylbutazone in female dairy cattle 20 months of age or older. (13) Cephalosporins (not including cephapirin) in cattle, swine, chickens, or turkeys: (i) For disease prevention purposes; (ii) At unapproved doses, frequencies, durations, or routes of administration; or (iii) If the drug is not approved for that species and production class. (b) The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in nonfood-producing animals: [Reserved] (c) [Reserved] (d) The following drugs, or classes of drugs, that are approved for treating or preventing influenza A, are prohibited from extralabel use in chickens, tur keys, and ducks: (1) Adamantanes. (2) Neuraminidase inhibitors. [62 FR 27947, May 22, 1997, as amended at 67 FR 5471, Feb. 6, 2002; 68 FR 9530, Feb. 28, 2003; 68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar. 22, 2006; 77 FR 745, Jan. 6, 2012] PART 556—TOLERANCES FOR RESI DUES OF NEW ANIMAL DRUGS IN FOOD Subpart A—General Provisions Sec. 556.1 General considerations; tolerances for residues of new animal drugs in food. Subpart B—Specific Tolerances for Residues of New Animal Drugs 556.34 Albendazole. 556.36 Altrenogest. 556.38 Amoxicillin. 556.40 Ampicillin. 556.50 Amprolium. 556.52 Apramycin. 556.68 Avilamycin. 556.70 Bacitracin. 556.100 Carbadox. 556.110 Carbomycin. 556.113 Ceftiofur. 556.115 Cephapirin. 556.118 Chloramine-T. 556.120 Chlorhexidine. 556.150 Chlortetracycline. 556.160 Clopidol. 556.163 Clorsulon. 556.165 Cloxacillin. 556.167 Colistimethate. 556.169 Danofloxacin. 556.170 Decoquinate. 556.180 Dichlorvos. 556.185 Diclazuril. 556.200 Dihydrostreptomycin. 556.225 Doramectin. 556.226 Enrofloxacin. 556.227 Eprinomectin. 556.230 Erythromycin. 556.240 Estradiol and related esters. 556.260 Ethopabate. 556.273 Famphur. 556.275 Fenbendazole. 556.277 Fenprostalene. 556.283 Florfenicol. 556.286 Flunixin. 556.292 Gamithromycin. 556.300 Gentamicin sulfate. 556.304 Gonadotropin. 556.308 Halofuginone hydrobromide. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00399 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 390 21 CFR Ch. I (4–1–16 Edition) § 556.1 556.310 Haloxon. 556.330 Hygromycin B. 556.344 Ivermectin. 556.346 Laidlomycin. 556.347 Lasalocid. 556.350 Levamisole hydrochloride. 556.360 Lincomycin. 556.375 Maduramicin ammonium. 556.380 Melengestrol acetate. 556.410 Metoserpate hydrochloride. 556.420 Monensin. 556.425 Morantel tartrate. 556.426 Moxidectin. 556.428 Narasin. 556.430 Neomycin. 556.440 Nequinate. 556.445 Nicarbazin. 556.460 Novobiocin. 556.470 Nystatin. 556.480 Oleandomycin. 556.490 Ormetoprim. 556.495 Oxfendazole. 556.500 Oxytetracycline. 556.510 Penicillin. 556.513 Piperazine. 556.515 Pirlimycin. 556.540 Progesterone. 556.560 Pyrantel tartrate. 556.570 Ractopamine. 556.580 Robenidine hydrochloride. 556.592 Salinomycin. 556.597 Semduramicin. 556.600 Spectinomycin. 556.610 Streptomycin. 556.620 Sulfabromomethazine sodium. 556.625 Sodium sulfachloropyrazine monohydrate. 556.630 Sulfachlorpyridazine. 556.640 Sulfadimethoxine. 556.650 Sulfaethoxypyridazine. 556.660 Sulfamerazine. 556.670 Sulfamethazine. 556.685 Sulfaquinoxaline. 556.700 Sulfomyxin. 556.710 Testosterone propionate. 556.720 Tetracycline. 556.730 Thiabendazole. 556.732 Tiamulin. 556.733 Tildipirosin. 556.735 Tilmicosin. 556.739 Trenbolone. 556.740 Tylosin. 556.741 Tripelennamine. 556.745 Tulathromycin. 556.748 Tylvalosin. 556.750 Virginiamycin. 556.760 Zeranol. 556.765 Zilpaterol. 556.770 Zoalene. AUTHORITY: 21 U.S.C. 342, 360b, 371. SOURCE: 40 FR 13942, Mar. 27, 1975, unless otherwise noted. Subpart A—General Provisions § 556.1 General considerations; toler ances for residues of new animal drugs in food. (a) Tolerances established in this part are based upon residues of drugs in edible products of food-producing ani mals treated with such drugs. Consid eration of an appropriate tolerance for a drug shall result in a conclusion ei ther that: (1) Finite residues will be present in the edible products—in which case a fi nite tolerance is required; or (2) It is not possible to determine whether finite residues will be incurred but there is reasonable expectation that they may be present—in which case a tolerance for negligible residue is required; or (3) The drug induces cancer when in gested by man or animal or, after tests which are appropriate for the evalua tion of the safety of such drug, has been shown to induce cancer in man or animal; however, such drug will not ad versely affect the animals for which it is intended, and no residue of such drug will be found by prescribed methods of analysis in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animal—in which case the accepted method of analysis shall be published or cited, if previously published and available elsewhere, in this part; or (4) It may or may not be possible to determine whether finite residues will be incurred but there is no reasonable expectation that they may be present— in which case the establishment of a tolerance is not required; or (5) The drug is such that it may be metabolized and/or assimilated in such form that any possible residue would be indistinguishable from normal tis sue constituents—in which case the es tablishment of a tolerance is not re quired. (b) No tolerance established pursuant to paragraph (a)(1) of this section will be set at any level higher than that re flected by the permitted use of the drug. (c) Any tolerance required pursuant to this section will, in addition to the VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00400 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 391 Food and Drug Administration, HHS § 556.68 toxicological considerations, be condi tioned on the availability of a prac ticable analytical method to determine the quantity of residue. Such method must be sensitive to and reliable at the established tolerance level or, in cer tain instances, may be sensitive at a higher level where such level is also deemed satisfactory and safe in light of the toxicity of the drug residue and of the unlikelihood of such residue’s ex ceeding the tolerance. Subpart B—Specific Tolerances for Residues of New Animal Drugs § 556.34 Albendazole. (a) Acceptable daily intake (ADI). The ADI for total residues of albendazole is 5 micrograms per kilogram of body weight per day. (b) Tolerances. The tolerances for albendazole 2-aminosulfone (marker residue) are: (1) Cattle—(i) Liver (target tissue): 0.2 parts per million (ppm). (ii) Muscle: 0.05 ppm. (2) Sheep—(i) Liver (target tissue): 0.25 ppm. (ii) Muscle: 0.05 ppm. (3) Goat—(i) Liver (target tissue): 0.25 ppm. (ii) [Reserved] (c) Related conditions of use. See § 520.45 of this chapter. [64 FR 1504, Jan. 11, 1999, as amended at 73 FR 11027, Feb. 29, 2008] § 556.36 Altrenogest. (a) Acceptable Daily Intake (ADI). The ADI for total residues of altrenogest is 0.04 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Swine—(i) Liver (the target tissue). The tolerance for altrenogest (the marker residue) is 4 parts per billion (ppb). (ii) Muscle. The tolerance for altrenogest (the marker residue) is 1 ppb. (2) [Reserved] [68 FR 62007, Oct. 31, 2003] § 556.38 Amoxicillin. A tolerance of 0.01 part per million is established for negligible residues of amoxicillin in milk and in the uncooked edible tissues of cattle. [49 FR 45422, Nov. 16, 1984] § 556.40 Ampicillin. A tolerance of 0.01 p/m is established for negligible residues of ampicillin in the uncooked edible tissues of swine and cattle and in milk. § 556.50 Amprolium. Tolerances are established as follows for residues of amprolium (1-(4-amino 2-n- propyl-5-pyrimidinylmethyl)-2 picolinium chloride hydrochloride): (a) In the edible tissues and in eggs of chickens and turkeys: (1) 1 part per million in uncooked liver and kidney. (2) 0.5 part per million in uncooked muscle tissue. (3) In eggs: (i) 8 parts per million in egg yolks. (ii) 4 parts per million in whole eggs. (b) In the edible tissues of calves: (1) 2.0 parts per million in uncooked fat. (2) 0.5 part per million in uncooked muscle tissue, liver, and kidney. (c) In the edible tissues of pheasants: (1) 1 part per million in uncooked liver. (2) 0.5 part per million in uncooked muscle. [40 FR 13942, Mar. 27, 1975, as amended at 50 FR 18472, May 1, 1985] § 556.52 Apramycin. A tolerance of 0.1 part per million is established for parent apramycin (marker residue) in kidney (target tis sue) of swine. The acceptable daily in take (ADI) for total residues of apramycin is 25 micrograms per kilo gram of body weight per day. [62 FR 40933, July 31, 1997] § 556.68 Avilamycin. (a) Acceptable Daily Intake (ADI). The ADI for total residues of avilamycin is 1.1 milligram per kilogram of body weight per day. (b) Tolerances. A tolerance for avilamycin is not required. (c) Related conditions of use. See § 558.68 of this chapter. [80 FR 61297, Oct. 13, 2015] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00401 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 392 21 CFR Ch. I (4–1–16 Edition) § 556.70 § 556.70 Bacitracin. (a) Acceptable daily intake (ADI). The ADI for total residues of bacitracin is 0.05 milligram per kilogram of body weight per day. (b) Tolerances. The tolerance for resi dues of bacitracin from zinc bacitracin or bacitracin methylenedisalicylate in uncooked edible tissues of cattle, swine, chickens, turkeys, pheasants, and quail, and in milk and eggs is 0.5 part per million. (c) Related conditions of use. See §§ 520.154a, 520.154c, 558.76, and 558.78 of this chapter. [65 FR 70791, Nov. 28, 2000, as amended at 81 FR 17608, Mar. 30, 2016] § 556.100 Carbadox. A tolerance of 30 parts per billion is established for residues of quinoxaline 2-carboxylic acid (marker residue) in liver (target tissue) of swine. [63 FR 13337, Mar. 19, 1998] § 556.110 Carbomycin. A tolerance of zero is established for residues of carbomycin in the uncooked edible tissues of chickens. § 556.113 Ceftiofur. (a) Acceptable daily intake and accept able single-dose intake—(1) Acceptable daily intake (ADI). The ADI for total residues of ceftiofur is 30 micrograms per kilogram of body weight per day. (2) Acceptable single-dose intake (ASDI). The ASDI total residues of ceftiofur is 0.830 milligrams per kilo gram of body weight. The ASDI is the amount of total residues of ceftiofur that may safely be consumed in a sin gle meal. The ASDI is used to derive the tolerance for residues of desfuroylceftiofur at the injection site. (b) Tolerances—(1) Poultry, and sheep. A tolerance for residues of ceftiofur in edible tissue is not required. (2) Swine. The tolerances for desfuroylceftiofur (marker residue) are: (i) Kidney (target tissue). 0.25 parts per million (ppm). (ii)Liver. 3 ppm. (iii) Muscle. 2 ppm. (3) Cattle. The tolerances for desfuroylceftiofur (marker residue) are: (i) Kidney (target tissue). 0.4 ppm. (ii) Liver. 2 ppm. (iii)Muscle. 1 ppm. (iv) Milk. 0.1 ppm. [63 FR 53579, Oct. 6, 1998, as amended at 68 FR 60296, Oct. 22, 2003; 69 FR 43892, July 23, 2004; 71 FR 39546, July 13, 2006] § 556.115 Cephapirin. A tolerance of 0.02 parts per million (ppm) is established for residues of cephapirin in the milk and 0.1 ppm in the uncooked edible tissues of dairy cattle. [40 FR 57454, Dec. 10, 1975] § 556.118 Chloramine-T. (a) Acceptable Daily Intake (ADI). The ADI for total residues of chloramine-T is 5 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Fish—(i) Muscle/ skin (target tissue). The tolerance for para-toluenesulfonamide (marker res idue) is 0.90 parts per million. (ii) [Reserved] (2) [Reserved] (c) Related conditions of use. See § 529.382 of this chapter. [79 FR 37621, July 2, 2014] § 556.120 Chlorhexidine. A tolerance of zero is established for residues of chlorhexidine in the uncooked edible tissues of calves. § 556.150 Chlortetracycline. (a) Acceptable daily intake (ADI). The ADI for total residues of tetracyclines including chlortetracycline, oxytetra cycline, and tetracycline is 25 micrograms per kilogram of body weight per day. (b) Tolerances. (1) Tolerances are es tablished for the sum of tetracycline residues in tissues of beef cattle, non lactating dairy cows, calves, swine, sheep, chickens, turkeys, and ducks, of 2 parts per million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kid ney. (2) A tolerance is established for resi dues of chlortetracycline in eggs of 0.4 ppm. [63 FR 52158, Sept. 30, 1998, as amended at 63 FR 57246, Oct. 27, 1998] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00402 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 393 Food and Drug Administration, HHS § 556.185 § 556.160 Clopidol. Tolerances for residues of clopidol (3,5-dichloro-2,6-dimethyl-4-pyridinol) in food are established as follows: (a) In cereal grains, vegetables, and fruits: 0.2 part per million. (b) In chickens and turkeys: (1) 15 parts per million in uncooked liver and kidney. (2) 5 parts per million in uncooked muscle. (c) In cattle, sheep, and goats: (1) 3 parts per million in uncooked kidney. (2) 1.5 parts per million in uncooked liver. (3) 0.2 part per million in uncooked muscle. (d) In swine: 0.2 part per million in uncooked edible tissues. (e) In milk: 0.02 part per million (neg ligible residue). § 556.163 Clorsulon. (a) Acceptable daily intake (ADI). The ADI for total residues of clorsulon is 8 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Kidney (the target tissue). The tolerance for par ent clorsulon (the marker residue) is 1.0 part per million. (ii) Muscle. The tolerance for parent clorsulon (the marker residue) is 0.1 part per million. (2) [Reserved] [66 FR 35544, July 6, 2001] § 556.165 Cloxacillin. A tolerance of 0.01 part per million is established for negligible residues of cloxacillin in the uncooked edible tis sues of cattle and in milk. [40 FR 28792, July 9, 1975] § 556.167 Colistimethate. A tolerance for residues of colistimethate in the edible tissues of chickens is not required. [63 FR 13123, Mar. 18, 1998] § 556.169 Danofloxacin. (a) Acceptable daily intake (ADI). The ADI for total residues of danofloxacin is 2.4 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par ent danofloxacin (the marker residue) is 0.2 part per million (ppm). (ii) Muscle. The tolerance for parent danofloxacin (the marker residue) is 0.2 ppm. (2) [Reserved] [67 FR 78973, Dec. 27, 2002] § 556.170 Decoquinate. (a) Acceptable daily intake (ADI). The ADI for total residues of decoquinate is 75 micrograms per kilogram of body weight per day. (b) Tolerances. Tolerances are estab lished for residues of decoquinate in the uncooked, edible tissues of chick ens, cattle, and goats as follows: (1) 1 part per million (ppm) in skel etal muscle. (2) 2 ppm in other tissues. [64 FR 10103, Mar. 2, 1999] § 556.180 Dichlorvos. A tolerance of 0.1 part per million is established for negligible residues of dichlorvos (2,2-dichlorovinyl dimethyl phosphate) in the edible tissues of swine. § 556.185 Diclazuril. (a) Acceptable daily intake (ADI). The ADI for total residues of diclazuril is 25 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Chickens—(i) Liver. The tolerance for parent diclazuril (the marker residue) is 3 parts per million (ppm). (ii) Muscle. The tolerance for parent diclazuril (the marker residue) is 0.5 ppm. (iii) Skin/fat. The tolerance for parent diclazuril (the marker residue) is 1 ppm. (2) Turkeys—(i) Liver. The tolerance for parent diclazuril (the marker res idue) is 3 ppm. (ii) Muscle. The tolerance for parent diclazuril (the marker residue) is 0.5 ppm. (iii) Skin/fat. The tolerance for parent diclazuril (the marker residue) is 1 ppm. [64 FR 35923, July 2, 1999. Redesignated and amended at 66 FR 62917, Dec. 4, 2001] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00403 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 394 21 CFR Ch. I (4–1–16 Edition) § 556.200 § 556.200 Dihydrostreptomycin. Tolerances are established for resi dues of dihydrostreptomycin in uncooked, edible tissues of cattle and swine of 2.0 parts per million (ppm) in kidney and 0.5 ppm in other tissues, and 0.125 ppm in milk. [59 FR 41977, Aug. 16, 1994] § 556.225 Doramectin. (a) Acceptable daily intake (ADI). The ADI for total residues of doramectin is 0.75 microgram per kilogram of body weight per day. (b) Tolerances—(1) Cattle. A tolerance of 100 parts per billion is established for parent doramectin (marker residue) in liver (target tissue) and of 30 parts per billion for parent doramectin in muscle. (2) Swine. A tolerance is established for parent doramectin (marker residue) in liver (target tissue) of 160 parts per billion. [63 FR 68184, Dec. 10, 1998] § 556.226 Enrofloxacin. (a) Acceptable daily intake (ADI). The ADI for total residues of enrofloxacin is 3 micrograms per kilogram of body weight per day. (b) Tolerances. The tolerances for enrofloxacin are: (1) Cattle—(i) Liver (target tissue). 0.1 part per million (ppm) desethylene ciprofloxacin (the marker residue). (ii) [Reserved] (2) Swine—(i) Liver (target tissue). 0.5 ppm enrofloxacin (the marker residue). (ii) [Reserved] (c) Related conditions of use. See § 522.812 of this chapter. [73 FR 21819, Apr. 23, 2008] § 556.227 Eprinomectin. (a) Acceptable daily intake (ADI). The ADI for total residues of eprinomectin is 10 micrograms per kilogram of body weight per day. (b) Tolerances. The tolerances for eprinomectin B1a (marker residue) are: (1) Cattle—(i) Liver (target tissue): 1.5 parts per million. (ii) Muscle: 100 parts per billion (ppb). (iii) Milk: 12 ppb. (2) [Reserved] (c) Related conditions of use. See §§ 522.814 and 524.814 of this chapter. [63 FR 59715, Nov. 5, 1998, as amended at 76 FR 72619, Nov. 25, 2011] § 556.230 Erythromycin. Tolerances for residues of erythro mycin in food are established as fol lows: (a) 0.1 part per million in uncooked edible tissues of beef cattle and swine. (b) Zero in milk. (c) 0.025 part per million in uncooked eggs. (d) 0.125 part per million (negligible residue) in uncooked edible tissues of chickens and turkeys. [40 FR 13942, Mar. 27, 1975, as amended at 58 FR 43795, Aug. 18, 1993] § 556.240 Estradiol and related esters. No residues of estradiol, resulting from the use of estradiol or any of the related esters, are permitted in excess of the following increments above the concentrations of estradiol naturally present in untreated animals: (a) In uncooked edible tissues of heif ers, steers, and calves: (1) 120 parts per trillion for muscle. (2) 480 parts per trillion for fat. (3) 360 parts per trillion for kidney. (4) 240 parts per trillion for liver. (b) [Reserved] [49 FR 13873, Apr. 9, 1984, as amended at 56 FR 67175, Dec. 30, 1991; 76 FR 16291, Mar. 23, 2011] § 556.260 Ethopabate. Tolerance for residues of ethopabate converted to metaphenetidine are es tablished in the edible tissues of chick ens as follows: (a) 1.5 parts per million in uncooked liver and kidney. (b) 0.5 part per million in uncooked muscle. § 556.273 Famphur. Tolerances are established for resi dues of famphur including its oxygen analog in or on meat, fat, or meat by products of cattle at 0.1 part per mil lion. [62 FR 55161, Oct. 23, 1997] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00404 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 395 Food and Drug Administration, HHS § 556.292 § 556.275 Fenbendazole. (a) Acceptable daily intake (ADI). The ADI for total residues of fenbendazole is 40 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par ent fenbendazole (the marker residue) is 0.8 part per million (ppm). (ii) Muscle. The tolerance for parent fenbendazole (the marker residue) is 0.4 ppm. (iii) Milk. The tolerance for fenbendazole sulfoxide metabolite (the marker residue in cattle milk) is 0.6 ppm. (2) Swine—(i) Liver (the target tissue). The tolerance for parent fenbendazole (the marker residue) is 6 ppm. (ii) Muscle. The tolerance for parent fenbendazole (the marker residue) is 2 ppm. (3) Turkeys—(i) Liver (the target tis sue). The tolerance for fenbendazole sulfone (the marker residue) is 6 ppm. (ii) Muscle. The tolerance for fenbendazole sulfone (the marker res idue) is 2 ppm. (4) Goats—(i) Liver (the target tissue). The tolerance for parent fenbendazole (the marker residue) is 0.8 ppm. (ii) Muscle. The tolerance for parent fenbendazole (the marker residue) is 0.4 ppm. [65 FR 20733, Apr. 18, 2000, as amended at 65 FR 41588, July 6, 2000; 65 FR 50914, Aug. 22, 2000] § 556.277 Fenprostalene. A tolerance for marker residue of fenprostalene in cattle is not needed. The safe concentrations for the total residues of fenprostalene in the uncooked edible tissues of cattle are 10 parts per billion in muscle, 20 parts per billion in liver, 30 parts per billion in kidney, 40 parts per billion in fat, and 100 parts per billion in the injection site. As used in this section ‘‘toler ance’’ refers to a concentration of a marker residue in the target tissue se lected to monitor for total residues of the drug in the target animal, and ‘‘safe concentrations’’ refer to the con centrations of total residues considered safe in edible tissues. [49 FR 26716, June 29, 1984] § 556.283 Florfenicol. (a) Acceptable daily intake (ADI). The ADI for total residues of florfenicol is 10 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for florfenicol amine (the marker residue) is 3.7 parts per million (ppm). (ii) Muscle. The tolerance for florfenicol amine (the marker residue) is 0.3 ppm. (2) Swine—(i) Liver (the target tissue). The tolerance for parent florfenicol (the marker residue) is 2.5 ppm. (ii) Muscle. The tolerance for parent florfenicol (the marker residue) is 0.2 ppm. (3) Freshwater-reared finfish (other than catfish) and salmonids. The toler ance for florfenicol amine (the marker residue) in muscle/skin (the target tis sues) is 1 ppm. (4) Catfish. The tolerance for florfenicol amine (the marker residue) in muscle (the target tissues) is 1 ppm. (c) Related conditions of use. See §§ 520.955, 522.955, 522.956, and 558.261 of this chapter. [76 FR 16291, Mar. 23, 2011, as amended at 81 FR 17608, Mar. 30, 2016] § 556.286 Flunixin. (a) Acceptable daily intake (ADI). The ADI for total residues of flunixin is 0.72 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle. The toler ance for flunixin free acid (the marker residue) is: (i) Liver (the target tissue). 125 parts per billion (ppb). (ii) Muscle. 25 ppb. (iii) Milk: 2 ppb 5-hydroxy flunixin. (2) Swine. The tolerance for flunixin free acid (the marker residue) is: (i) Liver (the target tissue). 30 ppb. (ii) Muscle. 25 ppb. (c) Related conditions of use. See §§ 522.956 and 522.970 of this chapter. [63 FR 38750, July 20, 1998, as amended at 69 FR 60309, Oct. 8, 2004; 70 FR 70999, Nov. 25, 2005; 76 FR 16291, Mar. 23, 2011] § 556.292 Gamithromycin. (a) Acceptable Daily Intake (ADI). The ADI for total residues of VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00405 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 396 21 CFR Ch. I (4–1–16 Edition) § 556.300 gamithromycin is 10 micrograms per kilogram of body weight per day. (b) Tolerances. The tolerances for gamithromycin (the marker residue) are: (1) Cattle—(i) Liver (the target tissue): 500 parts per billion (ppb). (ii) Muscle. 150 ppb. (2) [Reserved] (c) Related conditions of use. See § 522.1014 of this chapter. [76 FR 57907, Sept. 19, 2011] § 556.300 Gentamicin sulfate. (a) A tolerance of 0.1 part per million is established for negligible residues of gentamicin sulfate in the uncooked ed ible tissues of chickens and turkeys. (b) Tolerances are established for total residues of gentamicin in edible tissues of swine as follows: 0.1 part per million in muscle, 0.3 part per million in liver, and 0.4 part per million in fat and kidney. A microbiological deter minative procedure and an HPLC con firmatory procedure for gentamicin have been developed to assay gentamicin in kidney at 0.4 ppm. Since residues of gentamicin as the parent compound and total residues are equal, the marker (parent drug) residue con centration of 0.4 ppm in kidney cor responds to 0.4 ppm of total residue. [48 FR 791, Jan. 7, 1983, as amended at 61 FR 24441, May 15, 1996] § 556.304 Gonadotropin. (a) Acceptable daily intake (ADI). The ADI for residues of total gonadotropins (human chorionic gonadotropin and pregnant mare serum gonadotropin) is 42.25 I.U. per kilogram of body weight per day. (b) Tolerances. A tolerance for resi dues of gonadotropin in uncooked edi ble tissues of cattle or of fish is not re quired. [64 FR 48545, Sept. 7, 1999] § 556.308 Halofuginone hydrobromide. The marker residue selected to mon itor for total residues of halofuginone hydrobromide in broilers and turkeys is parent halofuginone hydrobromide and the target tissue selected is liver. A tolerance is established in broilers of 0.16 part per million and in turkeys of 0.13 part per million for parent halofuginone hydrobromide in liver. These marker residue concentrations in liver correspond to total residue concentrations of 0.3 part per million in liver. The safe concentrations for total residues of halofuginone hydrobromide in the uncooked edible tissues of broilers and turkeys are 0.1 part per million in muscle, 0.3 part per million in liver, and 0.2 part per mil lion in skin with adhering fat. As used in this section, ‘‘tolerance’’ refers to a concentration of a marker residue in the target tissue selected to monitor for total residues of the drug in the target animal, and ‘‘safe concentra tions’’ refers to the concentrations of total residues considered safe in edible tissues. [54 FR 28052, July 5, 1989, as amended at 56 FR 8711, Mar. 1, 1991; 57 FR 21209, May 19, 1992] § 556.310 Haloxon. A tolerance of 0.1 part per million is established for negligible residues of haloxon (3-chloro-7-hydroxy-4-methyl coumarin bis(2-chloroethyl) phosphate) in the edible tissues of cattle. [40 FR 13942, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980] § 556.330 Hygromycin B. A tolerance of zero is established for residues of hygromycin B in or on eggs and the uncooked edible tissues of swine and poultry. § 556.344 Ivermectin. (a) Acceptable Daily Intake (ADI). The ADI for total residues of ivermectin is 5 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Liver. A tolerance is established for 22,23 dihydroavermectin B1a (marker res idue) in liver (target tissue) as follows: (i) Cattle. 1.6 parts per million. (ii) Swine. 20 parts per billion. (iii) Sheep. 30 parts per billion. (iv) Reindeer. 15 parts per billion. (v) American bison. 15 parts per bil lion. (2) Muscle. Muscle residues are not in dicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00406 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 397 Food and Drug Administration, HHS § 556.420 (i) Swine. 20 parts per billion. (ii) Cattle. 650 parts per billion. (c) Related conditions of use. See §§ 520.1192, 520.1195, 520.1197, 522.1192, 522.1193, 524.1193, and 558.300 of this chapter. [63 FR 54352, Oct. 9, 1998, as amended at 64 FR 26671, May 17, 1999; 79 FR 64117, Oct. 28, 2014] § 556.346 Laidlomycin. (a) Acceptable daily intake (ADI). The ADI for total residues of laidlomycin is 7.5 micrograms per kilogram of body weight per day. (b) Tolerance. The tolerance for par ent laidlomycin (the marker residue) in the liver (the target tissue) of cattle is 0.2 part per million (ppm). [68 FR 42590, July 18, 2003] § 556.347 Lasalocid. (a) Acceptable daily intake (ADI). The ADI for total residues of lasalocid is 10 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle. The toler ance for parent lasalocid (the marker residue) in liver (the target tissue) is 0.7 part per million (ppm). (2) Chickens—(i) Skin with adhering fat (the target tissue). The tolerance for par ent lasalocid (the marker residue) is 1.2 ppm. (ii) Liver. The tolerance for parent lasalocid (the marker residue) is 0.4 ppm. (3) Turkeys—(i) Liver (the target tis sue). The tolerance for parent lasalocid (the marker residue) is 0.4 ppm. (ii) Skin with adhering fat. The toler ance for parent lasalocid (the marker residue) is 0.4 ppm. (4) Rabbits. The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 0.7 ppm. (5) Sheep. The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 1.0 ppm. [66 FR 19854, Apr. 18, 2001] § 556.350 Levamisole hydrochloride. A tolerance of 0.1 part per million is established for negligible residues of levamisole hydrochloride in the edible tissues of cattle, sheep, and swine. § 556.360 Lincomycin. (a) Acceptable daily intake (ADI). The ADI for total residues of lincomycin is 25 micrograms per kilogram of body weight per day. (b) Chickens. A tolerance for residues of lincomycin in chickens is not re quired. (c) Swine. Tolerances for lincomycin of 0.6 part per million in liver and 0.1 part per million in muscle are estab lished. [64 FR 13342, Mar. 18, 1999] § 556.375 Maduramicin ammonium. A tolerance is established for resi dues of maduramicin ammonium in chickens as follows: (a) A tolerance for maduramicin am monium (marker residue) in chickens is 0.38 parts per million in fat (target tissue). A tolerance refers to the con centration of marker residues in the target tissue used to monitor for total drug residues in the target animals. (b) The safe concentrations for total maduramicin ammonium residues in uncooked edible chicken tissues are: 0.24 parts per million in muscle; 0.72 parts per million in liver; 0.48 parts per million in skin; and 0.48 parts per mil lion in fat. A safe concentration refers to the total residue concentration con sidered safe in edible tissues. [54 FR 5229, Feb. 2, 1989] § 556.380 Melengestrol acetate. A tolerance of 25 parts per billion is established for residues of the parent compound, melengestrol acetate, in fat of cattle. [59 FR 41241, Aug. 11, 1994] § 556.410 Metoserpate hydrochloride. A tolerance of 0.02 part per million is established for negligible residues of metoserpate hydrochloride (methyl-o methyl-18-epireserpate hydrochloride) in uncooked edible tissues of chickens. § 556.420 Monensin. (a) Acceptable daily intake (ADI). The ADI for total residues of monensin is 12.5 micrograms per kilogram of body weight per day. (b) Tolerances. The tolerances for res idues of monensin are: VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00407 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 398 21 CFR Ch. I (4–1–16 Edition) § 556.425 (1) Cattle—(i) Liver. 0.10 part per mil lion (ppm). (ii) Muscle, kidney, and fat. 0.05 ppm. (iii) Milk. Not required. (2) Goats—(i) Edible tissues. 0.05 ppm. (ii) [Reserved] (3) Chickens, turkeys, and quail. A tol erance for residues of monensin in chickens, turkeys, and quail is not re quired. (c) Related conditions of use. See §§ 520.1448 and 558.355 of this chapter. [64 FR 5159, Feb. 3, 1999, as amended at 69 FR 68783, Nov. 26, 2004; 72 FR 56897, Oct. 5, 2007] § 556.425 Morantel tartrate. A tolerance of 0.7 part per million is established for N-methyl-1,3 propanediamine (MAPA, marker res idue) in the liver (target tissue) of cat tle and goats. A tolerance for residues of morantel tartrate in milk is not re quired. [59 FR 17922, Apr. 15, 1994] § 556.426 Moxidectin. (a) Acceptable daily intake (ADI). The ADI for total residues of moxidectin is 4 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Fat (the target tissue). The tolerance for parent moxidectin (the marker residue) is 900 parts per billion (ppb). (ii) Liver. The tolerance for parent moxidectin (the marker residue) is 200 ppb. (iii) Muscle. The tolerance for parent moxidectin (the marker residue) is 50 ppb. (iv) Milk. The tolerance for parent moxidectin (the marker residue) is 40 ppb. (2) Sheep—(i) Fat (the target tissue). The tolerance for parent moxidectin (the marker residue) is 900 parts per billion (ppb). (ii) Liver. The tolerance for parent moxidectin (the marker residue) is 200 ppb. (iii) Muscle. The tolerance for parent moxidectin (the marker residue) is 50 ppb. (c) Related conditions of use. See §§ 520.1454 and 522.1450 of this chapter. [65 FR 36617, June 9, 2000, as amended at 65 FR 76930, Dec. 8, 2000; 70 FR 36338, June 23, 2005; 70 FR 76163, Dec. 23, 2005] § 556.428 Narasin. (a) Acceptable daily intake (ADI). The ADI for total residues of narasin is 5 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Chickens (abdominal fat). The tolerance for parent narasin (the marker residue) is 480 parts per billion. (2) [Reserved] [66 FR 23589, May 9, 2001] § 556.430 Neomycin. (a) Acceptable daily intake (ADI). The ADI for total residues of neomycin is 6 micrograms per kilogram of body weight per day. (b) Tolerances. Tolerances are estab lished for residues of parent neomycin in uncooked edible tissues as follows: (1) Cattle, swine, sheep, and goats. 7.2 parts per million (ppm) in kidney (tar get tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in muscle. (2) Turkeys. 7.2 ppm in skin with adhearing fat, 3.6 ppm in liver, and 1.2 ppm in muscle. (3) Milk. A tolerance is established for residues of parent neomycin of 0.15 ppm. [64 FR 31498, June 11, 1999] § 556.440 Nequinate. A tolerance of 0.1 part per million is established for negligible residues of nequinate in the uncooked edible tis sues of chickens. § 556.445 Nicarbazin. A tolerance of 4 parts per million is established for residues of nicarbazin in uncooked chicken muscle, liver, skin, and kidney. [42 FR 56729, Oct. 28, 1977] § 556.460 Novobiocin. Tolerances for residues of novobiocin are established at 0.1 part per million in milk from dairy animals and 1 part per million in the uncooked edible tis sues of cattle, chickens, turkeys, and ducks. [47 FR 18590, Apr. 30, 1982] § 556.470 Nystatin. A tolerance of zero is established for residues of nystatin in or on eggs and VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00408 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 399 Food and Drug Administration, HHS § 556.540 the uncooked edible tissues of swine and poultry. § 556.480 Oleandomycin. Tolerances are established for neg ligible residues of oleandomycin in uncooked edible tissues of chickens, turkeys, and swine at 0.15 part per mil lion. § 556.490 Ormetoprim. (a) [Reserved] (b) Tolerances. A tolerance of 0.1 part per million (ppm) is established for negligible residues of ormetoprim in uncooked edible tissues of chickens, turkeys, ducks, salmonids, catfish, and chukar partridges. [64 FR 26672, May 17, 1999] § 556.495 Oxfendazole. Cattle: A tolerance is established for total oxfendazole residues in edible cattle tissues based on a marker res idue concentration of 0.8 part per mil lion (ppm) fenbendazole in the target liver tissue. A fenbendazole concentra tion of 0.8 ppm in liver corresponds to a total safe concentration of oxfendazole residues of 1.7 ppm in liver. The safe concentrations of total oxfendazole residues in other uncooked edible cattle tissues are: muscle, 0.84 ppm; kidney, 2.5 ppm; and fat, 3.3 ppm. A tolerance refers to the concentration of marker residue in the target tissue selected to monitor for total drug res idue in the target animal. A safe con centration is the total residue consid ered safe in edible tissue. [55 FR 46943, Nov. 8, 1990] § 556.500 Oxytetracycline. (a) Acceptable daily intake (ADI). The ADI for total tetracycline residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 micrograms per kilogram of body weight per day. (b) Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish, and lobster. Tolerances are established for the sum of residues of the tetracyclines including chlortetra cycline, oxytetracycline, and tetra cycline, in tissues and milk as follows: (1) 2 parts per million (ppm) in mus cle. (2) 6 ppm in liver. (3) 12 ppm in fat and kidney. (4) 0.3 ppm in milk. [63 FR 57246, Oct. 27, 1998, as amended at 66 FR 46370, Sept. 5, 2001; 69 FR 6557, Feb. 11, 2004] § 556.510 Penicillin. Tolerances are established for resi dues of penicillin and the salts of peni cillin in food as follows: (a) 0.05 part per million (negligible residue) in the uncooked edible tissues of cattle. (b) Zero in the uncooked edible tis sues of chickens, pheasants, quail, swine, and sheep; in eggs; and in milk or in any processed food in which such milk has been used. (c) 0.01 part per million in the uncooked edible tissues of turkeys. [40 FR 13942, Mar. 27, 1975, as amended at 43 FR 32749, July 28, 1978] § 556.513 Piperazine. A tolerance of 0.1 part per million pi perazine base is established for edible tissues of poultry and swine. [64 FR 23019, Apr. 29, 1999] § 556.515 Pirlimycin. (a) Acceptable daily intake (ADI). The ADI for total residues of pirlimycin is 0.01 milligrams per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par ent pirlimycin (the marker residue) is 0.5 part per million (ppm). (ii) Muscle. The tolerance for parent pirlimycin (the marker residue) is 0.3 ppm. (iii) Milk. The tolerance for parent pirlimycin (the marker residue in cat tle milk) is 0.4 ppm. (2) [Reserved] [65 FR 61091, Oct. 16, 2000] § 556.540 Progesterone. (a) [Reserved] (b) Tolerances. Residues of progester one are not permitted in excess of the following increments above the con centrations of progesterone naturally present in untreated animals: (1) Cattle and sheep—(i) Muscle: 5 parts per billion (ppb). (ii) Liver: 15 ppb. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00409 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 400 21 CFR Ch. I (4–1–16 Edition) § 556.560 (iii) Kidney: 30 ppb. (iv) Fat: 30 ppb. (2) [Reserved] (c) Related conditions of use. See §§ 522.1940 and 529.1940 of this chapter. [76 FR 57907, Sept. 19, 2011] § 556.560 Pyrantel tartrate. Tolerances are established for resi dues of pyrantel tartrate in edible tis sues of swine as follows: (a) 10 parts per million in liver and kidney. (b) 1 part per million in muscle. § 556.570 Ractopamine. (a) Acceptable Daily Intake (ADI). The ADI for total residues of ractopamine hydrochloride is 1.25 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for ractopamine hydrochloride (the mark er residue) is 0.09 parts per million (ppm). (ii) Muscle. The tolerance for ractopamine hydrochloride (the mark er residue) is 0.03 ppm. (2) Swine—(i) Liver (the target tissue). The tolerance for ractopamine hydro chloride (the marker residue) is 0.15 ppm. (ii) Muscle. The tolerance for ractopamine hydrochloride (the mark er residue) is 0.05 ppm. (3) Turkeys—(i) Liver (the target tis sue). The tolerance for ractopamine (the marker residue) is 0.45 ppm. (ii) Muscle. The tolerance for ractopamine (the marker residue) is 0.1 ppm. [68 FR 54659, Sept. 18, 2003, as amended at 73 FR 72715, Dec. 1, 2008] § 556.580 Robenidine hydrochloride. Tolerances are established for resi dues of robenidine hydrochloride in ed ible tissues of chickens as follows: (a) 0.2 part per million in skin and fat. (b) 0.1 part per million (negligible residue) in edible tissues other than skin and fat. § 556.592 Salinomycin. (a) Acceptable daily intake (ADI). The ADI for total residues of salinomycin is 0.005 milligram per kilogram of body weight per day. (b) [Reserved] [65 FR 70791, Nov. 28, 2000] § 556.597 Semduramicin. (a) Acceptable daily intake (ADI). The ADI for total residues of semduramicin is 180 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Broiler chickens. Tolerances are established for residues of parent semduramicin in uncooked edible tissues of 400 parts per billion (ppb) in liver and 130 ppb in muscle. (2) [Reserved] [64 FR 48296, Sept. 3, 1999] § 556.600 Spectinomycin. (a) Acceptable daily intake (ADI). The ADI for total residues of spectinomycin is 25 micrograms per kilogram of body weight per day. (b) Chickens and turkeys. A tolerance of 0.1 part per million (ppm) for neg ligible residues of spectinomycin in uncooked edible tissues of chickens and turkeys is established. (c) Cattle. A tolerance of 4 ppm for parent spectinomycin (marker residue) in kidney (target tissue) is established. A tolerance of 0.25 ppm for parent spectinomycin in cattle muscle is es tablished. [63 FR 24107, May 1, 1998; 63 FR 38304, July 16, 1998] § 556.610 Streptomycin. Tolerances are established for resi dues of streptomycin in uncooked, edi ble tissues of chickens, swine, and calves of 2.0 parts per million (ppm) in kidney and 0.5 ppm in other tissues. [58 FR 47211, Sept. 8, 1993] § 556.620 Sulfabromomethazine so dium. Tolerances for residues of sulfabromomethazine sodium in food are established as follows: (a) In the uncooked edible tissues of cattle at 0.1 part per million (negligible residue). (b) In milk at 0.01 part per million (negligible residue). [47 FR 30244, July 13, 1982] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00410 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 401 Food and Drug Administration, HHS § 556.732 § 556.625 Sodium sulfachloropyrazine monohydrate. A tolerance of zero is established for residues of sodium sulfachloropyrazine monohydrate in the uncooked edible tissues of chickens. § 556.630 Sulfachlorpyridazine. A tolerance of 0.1 part per million is established for negligible residues of sulfachlorpyridazine in uncooked edi ble tissues of calves and swine. § 556.640 Sulfadimethoxine. (a) [Reserved] (b) Tolerances. (1) A tolerance of 0.1 part per million (ppm) is established for negligible residues of sulfadimethoxine in uncooked edible tissues of chickens, turkeys, cattle, ducks, salmonids, catfish, and chukar partridges. (2) A tolerance of 0.01 ppm is estab lished for negligible residues of sulfadimethoxine in milk. [64 FR 26672, May 17, 1999] § 556.650 Sulfaethoxypyridazine. Tolerances for residues of sulfaethoxypyridazine in food are es tablished as follows: (a) Zero in the uncooked edible tis sues of swine and in milk. (b) 0.1 part per million (negligible residue) in uncooked edible tissues of cattle. § 556.660 Sulfamerazine. A tolerance of zero is established for residues of sulfamerazine (N1-[4-meth yl-2-pyrimidinyl]sulfanilamide) in the uncooked edible tissues of trout. § 556.670 Sulfamethazine. A tolerance of 0.1 part per million is established for negligible residues of sulfamethazine in the uncooked edible tissues of chickens, turkeys, cattle, and swine. [47 FR 25323, June 11, 1982] § 556.685 Sulfaquinoxaline. A tolerance of 0.1 part per million is established for negligible residues of sulfaquinoxaline in the uncooked edi ble tissues of chickens, turkeys, calves, and cattle. [61 FR 24443, May 15, 1996] § 556.700 Sulfomyxin. A tolerance of zero is established for residues of sulfomyxin (N-sulfomethyl polymyxin B sodium salt) in uncooked edible tissues from chickens and tur keys. § 556.710 Testosterone propionate. No residues of testosterone, resulting from the use of testosterone propio nate, are permitted in excess of the fol lowing increments above the con centrations of testosterone naturally present in untreated animals: (a) In uncooked edible tissues of heif ers: (1) 0.64 part per billion in muscle. (2) 2.6 parts per billion in fat. (3) 1.9 parts per billion in kidney. (4) 1.3 parts per billion in liver. (b) [Reserved] [52 FR 27683, July 23, 1987] § 556.720 Tetracycline. (a) Acceptable daily intake (ADI). The ADI for total tetracycline residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 micrograms per kilogram of body weight per day. (b) Tolerances. Tolerances are estab lished for the sum of tetracycline resi dues in tissues of calves, swine, sheep, chickens, and turkeys, of 2 parts per million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kidney. [63 FR 57246, Oct. 27, 1998] § 556.730 Thiabendazole. Tolerances are established at 0.1 part per million for negligible residues of thiabendazole in uncooked edible tis sues of cattle, goats, sheep, pheasants, and swine, and at 0.05 part per million for negligible residues in milk. [40 FR 13942, Mar. 27, 1975, as amended at 49 FR 29958, July 25, 1984] § 556.732 Tiamulin. A tolerance of 0.6 part per million is established for 8-alpha-hydroxymutilin VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00411 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 402 21 CFR Ch. I (4–1–16 Edition) § 556.733 (marker compound) in liver (target tis sue) of swine. [62 FR 12086, Mar. 14, 1997. Redesignated at 80 FR 13230, Mar. 13, 2015] § 556.733 Tildipirosin. (a) Acceptable Daily Intake (ADI). The ADI for total residues of tildipirosin is 50 micrograms per kilogram of body weight per day. (b) Tolerances. The tolerances for tildipirosin (the marker residue) are: (1) Cattle—(i) Liver (the target tissue): 10 parts per million. (ii) [Reserved] (2) [Reserved] (c) Related conditions of use. See § 522.2460 of this chapter. [77 FR 39391, July 3, 2012, as amended at 78 FR 52854, Aug. 27, 2013] § 556.735 Tilmicosin. (a) Acceptable daily intake (ADI). The ADI for total residues of tilmicosin is 25 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par ent tilmicosin (the marker residue) is 1.2 parts per million (ppm). (ii) Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm. (2) Swine—(i) Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 7.5 ppm. (ii) Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm. (3) Sheep—(i) Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 1.2 ppm. (ii) Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm. [64 FR 13679, Mar. 22, 1999, as amended at 67 FR 72368, Dec. 5, 2002; 78 FR 52854, Aug. 27, 2013] § 556.739 Trenbolone. (a) Acceptable daily intake (ADI). The ADI for total residues of trenbolone is 0.4 microgram per kilogram of body weight per day. (b) Tolerances. A tolerance for total trenbolone residues in uncooked edible tissues of cattle is not needed. [64 FR 18574, Apr. 15, 1999] § 556.740 Tylosin. Tolerances are established for resi dues of tylosin in edible products of animals as follows: (a) In chickens and turkeys: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kid ney. (b) In cattle: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney. (c) In swine: 0.2 part per million (neg ligible residue) in uncooked fat, mus cle, liver, and kidney. (d) In milk: 0.05 part per million (neg ligible residue). (e) In eggs: 0.2 part per million (neg ligible residue). § 556.741 Tripelennamine. A tolerance of 200 parts per billion (ppb) is established for residues of tripelennamine in uncooked edible tis sues of cattle and 20 ppb in milk. [62 FR 4164, Jan. 29, 1997] § 556.745 Tulathromycin. (a) Acceptable daily intake (ADI). The ADI for total residues of tulathromycin is 15 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for CP– 60,300 (the marker residue) is 5.5 parts per million (ppm). (ii) [Reserved] (2) Swine—(i) Kidney (the target tis sue). The tolerance for CP–60,300 (the marker residue) is 15 ppm. (ii) [Reserved] (c) Related conditions of use. See § 522.2630 of this chapter. [70 FR 39918, July 12, 2005] § 556.748 Tylvalosin. (a) Acceptable Daily Intake (ADI). The ADI for total residues of tylvalosin is 47.7 micrograms per kilogram of body weight per day. (b) Tolerances. A tolerance for tylvalosin in edible tissues of swine is not required. (c) Related conditions of use. See § 520.2645 of this chapter. [77 FR 55415, Sept. 10, 2012] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00412 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 403 Food and Drug Administration, HHS Pt. 558 § 556.750 Virginiamycin. (a) Acceptable daily intake (ADI). The ADI for total residues of virginiamycin is 250 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Swine. Tolerances are established for residues of virginiamycin in uncooked edible tis sues of 0.4 part per million (ppm) in kidney, skin, and fat, 0.3 ppm in liver, and 0.1 ppm in muscle. (2) Broiler chickens and cattle. A toler ance for residues of virginiamycin is not required. [64 FR 48296, Sept. 3, 1999] § 556.760 Zeranol. (a) Acceptable daily intake (ADI). The ADI for total residues of zeranol is 0.00125 milligrams per kilogram of body weight per day. (b) Tolerances. The tolerances for res idues of zeranol in edible tissues are: (1) Cattle. A tolerance is not needed. (2) Sheep. 20 parts per billion. (c) Related conditions of use. See § 522.2680 of this chapter. [40 FR 13942, Mar. 27, 1975, as amended at 54 FR 31950, Aug. 3, 1989; 67 FR 6867, Feb. 14, 2002; 70 FR 15759, Mar. 29, 2005] § 556.765 Zilpaterol. (a) Acceptable daily intake (ADI). The ADI for total residues of zilpaterol is 0.083 micrograms per kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for zilpaterol (the marker residue) is 12 parts per billion (ppb). (ii) Muscle. The tolerance for zilpaterol (the marker residue) is 10 ppb. (2) [Reserved] (c) Related conditions of use. See § 558.665 of this chapter. [71 FR 53005, Sept. 8, 2006, as amended at 81 FR 17608, Mar. 30, 2016] § 556.770 Zoalene. Tolerances are established for resi dues of zoalene (3,5-dinitro-o toluamide) and its metabolite 3-amino 5-nitro-o-toluamide in food as follows: (a) In edible tissues of chickens: (1) 6 parts per million in uncooked liver and kidney. (2) 3 parts per million in uncooked muscle tissue. (3) 2 parts per million in uncooked fat. (b) In edible tissues of turkeys: 3 parts per million in uncooked muscle tissue and liver. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Subpart A—General Provisions Sec. 558.3 Definitions and general considerations applicable to this part. 558.4 Requirement of a medicated feed mill license. 558.5 Requirements for liquid medicated feed. 558.6 Veterinary feed directive drugs. 558.15 Antibiotic, nitrofuran, and sul fonamide drugs in the feed of animals. Subpart B—Specific New Animal Drugs For Use in Animal Feeds 558.55 Amprolium. 558.58 Amprolium and ethopabate. 558.59 Apramycin. 558.68 Avilamycin. 558.76 Bacitracin methylenedisalicylate. 558.78 Bacitracin zinc. 558.95 Bambermycins. 558.115 Carbadox. 558.128 Chlortetracycline. 558.140 Chlortetracycline and sulfamethazine. 558.145 Chlortetracycline, procaine peni cillin, and sulfamethazine. 558.175 Clopidol. 558.185 Coumaphos. 558.195 Decoquinate. 558.198 Diclazuril. 558.205 Dichlorvos. 558.235 Efrotomycin. 558.248 Erythromycin. 558.254 Famphur. 558.258 Fenbendazole. 558.261 Florfenicol. 558.265 Halofuginone hydrobromide. 558.274 Hygromycin B. 558.295 Iodinated casein. 558.300 Ivermectin. 558.305 Laidlomycin. 558.311 Lasalocid. 558.325 Lincomycin. 558.340 Maduramicin. 558.342 Melengestrol. 558.348 Mibolerone. 558.355 Monensin. 558.360 Morantel tartrate. 558.363 Narasin. 558.364 Neomycin sulfate. 558.365 Nequinate. 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