21 CFR Ch. I (4–1–20 Edition) § 556.510

Pt. 556 21 CFR Ch. I (4–1–19 Edition)

(i) For disease prevention purposes; 556.227 Eprinomectin. (ii) At unapproved doses, frequencies, 556.230 Erythromycin. durations, or routes of administration; 556.240 Estradiol and related esters. or 556.260 Ethopabate. 556.273 Famphur. (iii) If the drug is not approved for 556.275 Fenbendazole. that species and production class. 556.277 Fenprostalene. (b) The following drugs, families of 556.283 Florfenicol. drugs, and substances are prohibited 556.286 Flunixin. for extralabel animal and human drug 556.292 Gamithromycin. uses in nonfood-producing animals: 556.300 Gentamicin sulfate. [Reserved] 556.304 Gonadotropin. 556.308 Halofuginone hydrobromide. (c) [Reserved] 556.310 Haloxon. (d) The following drugs, or classes of 556.330 Hygromycin B. drugs, that are approved for treating or 556.344 Ivermectin. preventing influenza A, are prohibited 556.346 Laidlomycin. from extralabel use in chickens, tur- 556.347 Lasalocid. keys, and ducks: 556.350 Levamisole hydrochloride. (1) Adamantanes. 556.360 Lincomycin. (2) Neuraminidase inhibitors. 556.375 Maduramicin ammonium. 556.380 Melengestrol acetate. [62 FR 27947, May 22, 1997, as amended at 67 556.410 Metoserpate hydrochloride. FR 5471, Feb. 6, 2002; 68 FR 9530, Feb. 28, 2003; 556.420 Monensin. 68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar. 556.425 Morantel tartrate. 22, 2006; 77 FR 745, Jan. 6, 2012] 556.426 Moxidectin. 556.428 Narasin. 556.430 Neomycin. PART 556—TOLERANCES FOR RESI- 556.445 Nicarbazin. DUES OF NEW ANIMAL DRUGS IN 556.460 Novobiocin. FOOD 556.470 Nystatin. 556.490 Ormetoprim. 556.495 Oxfendazole. Subpart A—General Provisions 556.500 Oxytetracycline. Sec. 556.510 Penicillin. 556.1 General considerations; tolerances for 556.513 Piperazine. residues of new animal drugs in food. 556.515 Pirlimycin. 556.540 Progesterone. Subpart B—Specific Tolerances for 556.560 Pyrantel tartrate. Residues of New Animal Drugs 556.570 Ractopamine. 556.580 Robenidine hydrochloride. 556.34 Albendazole. 556.592 Salinomycin. 556.36 Altrenogest. 556.597 Semduramicin. 556.38 Amoxicillin. 556.600 Spectinomycin. 556.40 Ampicillin. 556.610 Streptomycin. 556.50 Amprolium. 556.620 Sulfabromomethazine sodium. 556.52 Apramycin. 556.625 Sodium sulfachloropyrazine 556.68 Avilamycin. monohydrate. 556.70 Bacitracin. 556.630 Sulfachlorpyridazine. 556.100 Carbadox. 556.640 Sulfadimethoxine. 556.110 Carbomycin. 556.650 Sulfaethoxypyridazine. 556.113 Ceftiofur. 556.660 Sulfamerazine. 556.115 Cephapirin. 556.670 Sulfamethazine. 556.118 Chloramine-T. 556.685 Sulfaquinoxaline. 556.120 Chlorhexidine. 556.700 Sulfomyxin. 556.150 Chlortetracycline. 556.710 Testosterone propionate. 556.160 Clopidol. 556.720 Tetracycline. 556.163 Clorsulon. 556.730 Thiabendazole. 556.165 Cloxacillin. 556.732 Tiamulin. 556.167 Colistimethate. 556.733 Tildipirosin. 556.169 Danofloxacin. 556.735 Tilmicosin. 556.170 Decoquinate. 556.739 Trenbolone. 556.180 Dichlorvos. 556.740 Tylosin. 556.185 Diclazuril. 556.741 Tripelennamine. 556.200 Dihydrostreptomycin. 556.745 Tulathromycin. 556.225 Doramectin. 556.748 Tylvalosin. 556.226 Enrofloxacin. 556.750 Virginiamycin.

396

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00406 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 556.36

556.760 Zeranol. be set at any level higher than that re- 556.765 Zilpaterol. flected by the permitted use of the 556.770 Zoalene. drug. AUTHORITY: 21 U.S.C. 342, 360b, 371. (c) Any tolerance required pursuant SOURCE: 40 FR 13942, Mar. 27, 1975, unless to this section will, in addition to the otherwise noted. toxicological considerations, be condi- tioned on the availability of a prac- Subpart A—General Provisions ticable analytical method to determine the quantity of residue. Such method § 556.1 General considerations; toler- must be sensitive to and reliable at the ances for residues of new animal established tolerance level or, in cer- drugs in food. tain instances, may be sensitive at a (a) Tolerances established in this higher level where such level is also part are based upon residues of drugs in deemed satisfactory and safe in light of edible products of food-producing ani- the toxicity of the drug residue and of mals treated with such drugs. Consid- the unlikelihood of such residue’s ex- eration of an appropriate tolerance for ceeding the tolerance. a drug shall result in a conclusion ei- ther that: Subpart B—Specific Tolerances for (1) Finite residues will be present in Residues of New Animal Drugs the edible products—in which case a finite tolerance is required; or § 556.34 Albendazole. (2) It is not possible to determine (a) Acceptable daily intake (ADI). The whether finite residues will be incurred ADI for total residues of albendazole is but there is reasonable expectation 5 micrograms per kilogram of body that they may be present—in which weight per day. case a tolerance for negligible residue (b) The tolerances for is required; or Tolerances. (3) The drug induces cancer when in- albendazole 2-aminosulfone (marker gested by man or animal or, after tests residue) are: which are appropriate for the evalua- (1) Cattle—(i) Liver (target tissue): 0.2 tion of the safety of such drug, has parts per million (ppm). been shown to induce cancer in man or (ii) Muscle: 0.05 ppm. animal; however, such drug will not ad- (2) Sheep—(i) Liver (target tissue): 0.25 versely affect the animals for which it ppm. is intended, and no residue of such drug (ii) Muscle: 0.05 ppm. will be found by prescribed methods of (3) Goat—(i) Liver (target tissue): 0.25 analysis in any edible portion of such ppm. animals after slaughter or in any food (ii) [Reserved] yielded by or derived from the living (c) Related conditions of use. See animal—in which case the accepted § 520.45 of this chapter. method of analysis shall be published [64 FR 1504, Jan. 11, 1999, as amended at 73 or cited, if previously published and FR 11027, Feb. 29, 2008] available elsewhere, in this part; or (4) It may or may not be possible to § 556.36 Altrenogest. determine whether finite residues will (a) Acceptable Daily Intake (ADI). The be incurred but there is no reasonable ADI for total residues of altrenogest is expectation that they may be present— 0.04 micrograms per kilogram of body in which case the establishment of a weight per day. tolerance is not required; or (b) Tolerances—(1) Swine—(i) Liver (the (5) The drug is such that it may be target tissue). The tolerance for metabolized and/or assimilated in such altrenogest (the marker residue) is 4 form that any possible residue would parts per billion (ppb). be indistinguishable from normal tis- (ii) Muscle. The tolerance for sue constituents—in which case the es- altrenogest (the marker residue) is 1 tablishment of a tolerance is not re- ppb. quired. (2) [Reserved] (b) No tolerance established pursuant to paragraph (a)(1) of this section will [68 FR 62007, Oct. 31, 2003]

397

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00407 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 556.38 21 CFR Ch. I (4–1–19 Edition)

§ 556.38 Amoxicillin. (c) Related conditions of use. See A tolerance of 0.01 part per million is § 558.68 of this chapter. established for negligible residues of [80 FR 61297, Oct. 13, 2015] amoxicillin in milk and in the uncooked edible tissues of cattle. § 556.70 Bacitracin. [49 FR 45422, Nov. 16, 1984] (a) Acceptable daily intake (ADI). The ADI for total residues of bacitracin is § 556.40 Ampicillin. 0.05 milligram per kilogram of body weight per day. A tolerance of 0.01 p/m is established (b) Tolerances. The tolerance for resi- for negligible residues of ampicillin in dues of bacitracin from zinc bacitracin the uncooked edible tissues of swine or bacitracin methylenedisalicylate in and cattle and in milk. uncooked edible tissues of cattle, § 556.50 Amprolium. swine, chickens, turkeys, pheasants, and quail, and in milk and eggs is 0.5 Tolerances are established as follows part per million. for residues of amprolium (1-(4-amino- (c) Related conditions of use. See 2-n- propyl-5-pyrimidinylmethyl)-2- §§ 520.154a, 520.154c, 558.76, and 558.78 of picolinium chloride hydrochloride): this chapter. (a) In the edible tissues and in eggs of chickens and turkeys: [65 FR 70791, Nov. 28, 2000, as amended at 81 (1) 1 part per million in uncooked FR 17608, Mar. 30, 2016] liver and kidney. § 556.100 Carbadox. (2) 0.5 part per million in uncooked muscle tissue. A tolerance of 30 parts per billion is (3) In eggs: established for residues of quinoxaline- (i) 8 parts per million in egg yolks. 2-carboxylic acid (marker residue) in (ii) 4 parts per million in whole eggs. liver (target tissue) of swine. (b) In the edible tissues of calves: [63 FR 13337, Mar. 19, 1998] (1) 2.0 parts per million in uncooked fat. § 556.110 Carbomycin. (2) 0.5 part per million in uncooked A tolerance of zero is established for muscle tissue, liver, and kidney. residues of carbomycin in the uncooked (c) In the edible tissues of pheasants: edible tissues of chickens. (1) 1 part per million in uncooked liver. § 556.113 Ceftiofur. (2) 0.5 part per million in uncooked (a) Acceptable daily intake and accept- muscle. able single-dose intake—(1) Acceptable [40 FR 13942, Mar. 27, 1975, as amended at 50 daily intake (ADI). The ADI for total FR 18472, May 1, 1985] residues of ceftiofur is 30 micrograms per kilogram of body weight per day. § 556.52 Apramycin. (2) Acceptable single-dose intake A tolerance of 0.1 part per million is (ASDI). The ASDI total residues of established for parent apramycin ceftiofur is 0.830 milligrams per kilo- (marker residue) in kidney (target tis- gram of body weight. The ASDI is the sue) of swine. The acceptable daily in- amount of total residues of ceftiofur take (ADI) for total residues of that may safely be consumed in a sin- apramycin is 25 micrograms per kilo- gle meal. The ASDI is used to derive gram of body weight per day. the tolerance for residues of desfuroylceftiofur at the injection site. [62 FR 40933, July 31, 1997] (b) Tolerances—(1) Poultry, and sheep. A tolerance for residues of ceftiofur in § 556.68 Avilamycin. edible tissue is not required. (a) Acceptable Daily Intake (ADI). The (2) Swine. The tolerances for ADI for total residues of avilamycin is desfuroylceftiofur (marker residue) 1.1 milligram per kilogram of body are: weight per day. (i) Kidney (target tissue). 0.25 parts per (b) Tolerances. A tolerance for million (ppm). avilamycin is not required. (ii) Liver. 3 ppm.

398

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00408 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 556.167

(iii) Muscle. 2 ppm. (2) A tolerance is established for resi- (3) Cattle. The tolerances for dues of chlortetracycline in eggs of 0.4 desfuroylceftiofur (marker residue) ppm. are: [63 FR 52158, Sept. 30, 1998, as amended at 63 (i) Kidney (target tissue). 0.4 ppm. FR 57246, Oct. 27, 1998] (ii) Liver. 2 ppm. (iii) Muscle. 1 ppm. § 556.160 Clopidol. (iv) Milk. 0.1 ppm. Tolerances for residues of clopidol (3,5-dichloro-2,6-dimethyl-4-pyridinol) [63 FR 53579, Oct. 6, 1998, as amended at 68 FR 60296, Oct. 22, 2003; 69 FR 43892, July 23, 2004; in food are established as follows: 71 FR 39546, July 13, 2006] (a) In cereal grains, vegetables, and fruits: 0.2 part per million. § 556.115 Cephapirin. (b) In chickens and turkeys: A tolerance of 0.02 parts per million (1) 15 parts per million in uncooked liver and kidney. (ppm) is established for residues of (2) 5 parts per million in uncooked cephapirin in the milk and 0.1 ppm in muscle. the uncooked edible tissues of dairy (c) In cattle, sheep, and goats: cattle. (1) 3 parts per million in uncooked [40 FR 57454, Dec. 10, 1975] kidney. (2) 1.5 parts per million in uncooked § 556.118 Chloramine-T. liver. (a) Acceptable Daily Intake (ADI). The (3) 0.2 part per million in uncooked ADI for total residues of chloramine-T muscle. is 5 micrograms per kilogram of body (d) In swine: 0.2 part per million in weight per day. uncooked edible tissues. (b) Tolerances—(1) Fish—(i) Muscle/ (e) In milk: 0.02 part per million (neg- skin (target tissue). The tolerance for ligible residue). para-toluenesulfonamide (marker res- § 556.163 Clorsulon. idue) is 0.90 parts per million. (ii) [Reserved] (a) Acceptable daily intake (ADI). The (2) [Reserved] ADI for total residues of clorsulon is 8 (c) Related conditions of use. See micrograms per kilogram of body § 529.382 of this chapter. weight per day. (b) Tolerances—(1) Cattle—(i) Kidney [79 FR 37621, July 2, 2014] (the target tissue). The tolerance for parent clorsulon (the marker residue) is § 556.120 Chlorhexidine. 1.0 part per million. A tolerance of zero is established for (ii) Muscle. The tolerance for parent residues of chlorhexidine in the clorsulon (the marker residue) is 0.1 uncooked edible tissues of calves. part per million. (2) [Reserved] § 556.150 Chlortetracycline. [66 FR 35544, July 6, 2001] (a) Acceptable daily intake (ADI). The ADI for total residues of tetracyclines § 556.165 Cloxacillin. including chlortetracycline, oxytetra- A tolerance of 0.01 part per million is cycline, and tetracycline is 25 established for negligible residues of micrograms per kilogram of body cloxacillin in the uncooked edible tis- weight per day. sues of cattle and in milk. (b) Tolerances. (1) Tolerances are es- [40 FR 28792, July 9, 1975] tablished for the sum of tetracycline residues in tissues of beef cattle, non- § 556.167 Colistimethate. lactating dairy cows, calves, swine, sheep, chickens, turkeys, and ducks, of A tolerance for residues of colistimethate in the edible tissues of 2 parts per million (ppm) in muscle, 6 chickens is not required. ppm in liver, and 12 ppm in fat and kidney. [63 FR 13123, Mar. 18, 1998]

399

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00409 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 556.169 21 CFR Ch. I (4–1–19 Edition)

§ 556.169 Danofloxacin. (iii) Skin/fat. The tolerance for parent diclazuril (the marker residue) is 1 (a) Acceptable daily intake (ADI). The ppm. ADI for total residues of danofloxacin is 2.4 micrograms per kilogram of body [64 FR 35923, July 2, 1999. Redesignated and weight per day. amended at 66 FR 62917, Dec. 4, 2001] (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par- § 556.200 Dihydrostreptomycin. ent danofloxacin (the marker residue) Tolerances are established for resi- is 0.2 part per million (ppm). dues of dihydrostreptomycin in (ii) Muscle. The tolerance for parent uncooked, edible tissues of cattle and danofloxacin (the marker residue) is 0.2 swine of 2.0 parts per million (ppm) in ppm. kidney and 0.5 ppm in other tissues, (2) [Reserved] and 0.125 ppm in milk. [67 FR 78973, Dec. 27, 2002] [59 FR 41977, Aug. 16, 1994]

§ 556.170 Decoquinate. § 556.225 Doramectin. (a) Acceptable daily intake (ADI). The (a) Acceptable daily intake (ADI). The ADI for total residues of decoquinate is ADI for total residues of doramectin is 75 micrograms per kilogram of body 0.75 microgram per kilogram of body weight per day. weight per day. (b) Tolerances. Tolerances are estab- (b) Tolerances—(1) Cattle. A tolerance lished for residues of decoquinate in of 100 parts per billion is established the uncooked, edible tissues of chick- for parent doramectin (marker residue) ens, cattle, and goats as follows: in liver (target tissue) and of 30 parts (1) 1 part per million (ppm) in skel- per billion for parent doramectin in etal muscle. muscle. (2) 2 ppm in other tissues. (2) Swine. A tolerance is established for parent doramectin (marker residue) [64 FR 10103, Mar. 2, 1999] in liver (target tissue) of 160 parts per billion. § 556.180 Dichlorvos. A tolerance of 0.1 part per million is [63 FR 68184, Dec. 10, 1998] established for negligible residues of § 556.226 Enrofloxacin. dichlorvos (2,2-dichlorovinyl dimethyl phosphate) in the edible tissues of (a) Acceptable daily intake (ADI). The swine. ADI for total residues of enrofloxacin is 3 micrograms per kilogram of body § 556.185 Diclazuril. weight per day. (b) Tolerances. The tolerances for (a) Acceptable daily intake (ADI). The enrofloxacin are: ADI for total residues of diclazuril is 25 (1) Cattle—(i) Liver (target tissue). 0.1 micrograms per kilogram of body part per million (ppm) desethylene weight per day. ciprofloxacin (the marker residue). (b) Tolerances—(1) Chickens—(i) Liver. (ii) [Reserved] The tolerance for parent diclazuril (the (2) Swine—(i) Liver (target tissue). 0.5 marker residue) is 3 parts per million ppm enrofloxacin (the marker residue). (ppm). (ii) [Reserved] (ii) Muscle. The tolerance for parent (c) Related conditions of use. See diclazuril (the marker residue) is 0.5 § 522.812 of this chapter. ppm. (iii) Skin/fat. The tolerance for parent [73 FR 21819, Apr. 23, 2008] diclazuril (the marker residue) is 1 ppm. § 556.227 Eprinomectin. (2) Turkeys—(i) Liver. The tolerance (a) Acceptable daily intake (ADI). The for parent diclazuril (the marker res- ADI for total residues of eprinomectin idue) is 3 ppm. is 10 micrograms per kilogram of body (ii) Muscle. The tolerance for parent weight per day. diclazuril (the marker residue) is 0.5 (b) Tolerances. The tolerances for ppm. eprinomectin B1a (marker residue) are: 400

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00410 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 556.277

(1) Cattle—(i) Liver (target tissue): 1.5 products of cattle at 0.1 part per mil- parts per million. lion. (ii) Muscle: 100 parts per billion (ppb). [62 FR 55161, Oct. 23, 1997] (iii) Milk: 12 ppb. (2) [Reserved] § 556.275 Fenbendazole. (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The §§ 522.814 and 524.814 of this chapter. ADI for total residues of fenbendazole [63 FR 59715, Nov. 5, 1998, as amended at 76 is 40 micrograms per kilogram of body FR 72619, Nov. 25, 2011] weight per day. (b) Tolerances—(1) Cattle—(i) Liver § 556.230 Erythromycin. (the target tissue). The tolerance for par- Tolerances for residues of erythro- ent fenbendazole (the marker residue) mycin in food are established as fol- is 0.8 part per million (ppm). lows: (ii) Muscle. The tolerance for parent (a) 0.1 part per million in uncooked fenbendazole (the marker residue) is 0.4 edible tissues of beef cattle and swine. ppm. (b) Zero in milk. (iii) Milk. The tolerance for (c) 0.025 part per million in uncooked fenbendazole sulfoxide metabolite (the eggs. marker residue in cattle milk) is 0.6 ppm. (d) 0.125 part per million (negligible (2) Swine—(i) Liver (the target tissue). residue) in uncooked edible tissues of The tolerance for parent fenbendazole chickens and turkeys. (the marker residue) is 3.2 ppm. [40 FR 13942, Mar. 27, 1975, as amended at 58 (ii) Muscle. The tolerance for parent FR 43795, Aug. 18, 1993] fenbendazole (the marker residue) is 2 ppm. § 556.240 Estradiol and related esters. (3) Chickens—(i) Liver (the target tis- No residues of estradiol, resulting sue). The tolerance for fenbendazole from the use of estradiol or any of the sulfone (the marker residue) is 5.2 ppm. related esters, are permitted in excess (ii) Eggs. The tolerance for of the following increments above the fenbendazole sulfone (the marker res- concentrations of estradiol naturally idue) is 1.8 ppm. present in untreated animals: (4) Turkeys—(i) Liver (the target tis- (a) In uncooked edible tissues of heif- sue). The tolerance for fenbendazole ers, steers, and calves: sulfone (the marker residue) is 6 ppm. (1) 120 parts per trillion for muscle. (ii) Muscle. The tolerance for (2) 480 parts per trillion for fat. fenbendazole sulfone (the marker res- (3) 360 parts per trillion for kidney. idue) is 2 ppm. (4) 240 parts per trillion for liver. (5) Goats—(i) Liver (the target tissue). (b) [Reserved] The tolerance for parent fenbendazole (the marker residue) is 0.8 ppm. [49 FR 13873, Apr. 9, 1984, as amended at 56 (ii) Muscle. The tolerance for parent FR 67175, Dec. 30, 1991; 76 FR 16291, Mar. 23, fenbendazole (the marker residue) is 0.4 2011] ppm. (c) Related conditions of use. See § 556.260 Ethopabate. §§ 520.905a, 520.905c, 520.905d, 520.905e, Tolerance for residues of ethopabate and 558.258 of this chapter. converted to metaphenetidine are es- [65 FR 20733, Apr. 18, 2000, as amended at 65 tablished in the edible tissues of chick- FR 41588, July 6, 2000; 65 FR 50914, Aug. 22, ens as follows: 2000; 81 FR 22524, Apr. 18, 2016; 83 FR 48947, (a) 1.5 parts per million in uncooked Sept. 28, 2018] liver and kidney. (b) 0.5 part per million in uncooked § 556.277 Fenprostalene. muscle. A tolerance for marker residue of fenprostalene in cattle is not needed. § 556.273 Famphur. The safe concentrations for the total Tolerances are established for resi- residues of fenprostalene in the dues of famphur including its oxygen uncooked edible tissues of cattle are 10 analog in or on meat, fat, or meat by- parts per billion in muscle, 20 parts per

401

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00411 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 556.283 21 CFR Ch. I (4–1–19 Edition)

billion in liver, 30 parts per billion in (2) Swine. The tolerance for flunixin kidney, 40 parts per billion in fat, and free acid (the marker residue) is: 100 parts per billion in the injection (i) Liver (the target tissue). 30 ppb. site. As used in this section ‘‘toler- (ii) Muscle. 25 ppb. ance’’ refers to a concentration of a (c) Related conditions of use. See marker residue in the target tissue se- §§ 522.956, 522.970, and 524.970 of this lected to monitor for total residues of chapter. the drug in the target animal, and [63 FR 38750, July 20, 1998, as amended at 69 ‘‘safe concentrations’’ refer to the con- FR 60309, Oct. 8, 2004; 70 FR 70999, Nov. 25, centrations of total residues considered 2005; 76 FR 16291, Mar. 23, 2011; 83 FR 13635, safe in edible tissues. Mar. 30, 2018]

[49 FR 26716, June 29, 1984] § 556.292 Gamithromycin. § 556.283 Florfenicol. (a) Acceptable Daily Intake (ADI). The ADI for total residues of (a) Acceptable daily intake (ADI). The gamithromycin is 10 micrograms per ADI for total residues of florfenicol is kilogram of body weight per day. 10 micrograms per kilogram of body (b) Tolerances. The tolerances for weight per day. gamithromycin (the marker residue) (b) Tolerances—(1) Cattle—(i) Liver are: (the target tissue). The tolerance for (1) Cattle—(i) Liver (the target tissue): florfenicol amine (the marker residue) 500 parts per billion (ppb). is 3.7 parts per million (ppm). (ii) Muscle. 150 ppb. (ii) Muscle. The tolerance for (2) [Reserved] florfenicol amine (the marker residue) (c) Related conditions of use. See is 0.3 ppm. § 522.1014 of this chapter. (2) Swine—(i) Liver (the target tissue). The tolerance for parent florfenicol [76 FR 57907, Sept. 19, 2011] (the marker residue) is 2.5 ppm. § 556.300 Gentamicin sulfate. (ii) Muscle. The tolerance for parent florfenicol (the marker residue) is 0.2 (a) A tolerance of 0.1 part per million ppm. is established for negligible residues of gentamicin sulfate in the uncooked ed- (3) Freshwater-reared finfish (other ible tissues of chickens and turkeys. than catfish) and salmonids. The toler- (b) Tolerances are established for ance for florfenicol amine (the marker total residues of gentamicin in edible residue) in muscle/skin (the target tis- tissues of swine as follows: 0.1 part per sues) is 1 ppm. million in muscle, 0.3 part per million (4) Catfish. The tolerance for in liver, and 0.4 part per million in fat florfenicol amine (the marker residue) and kidney. A microbiological deter- in muscle (the target tissues) is 1 ppm. minative procedure and an HPLC con- (c) Related conditions of use. See firmatory procedure for gentamicin §§ 520.955, 522.955, 522.956, and 558.261 of have been developed to assay this chapter. gentamicin in kidney at 0.4 ppm. Since [76 FR 16291, Mar. 23, 2011, as amended at 81 residues of gentamicin as the parent FR 17608, Mar. 30, 2016] compound and total residues are equal, the marker (parent drug) residue con- § 556.286 Flunixin. centration of 0.4 ppm in kidney cor- (a) Acceptable daily intake (ADI). The responds to 0.4 ppm of total residue. ADI for total residues of flunixin is 0.72 [48 FR 791, Jan. 7, 1983, as amended at 61 FR micrograms per kilogram of body 24441, May 15, 1996] weight per day. (b) Tolerances—(1) Cattle. The toler- § 556.304 Gonadotropin. ance for flunixin free acid (the marker (a) Acceptable daily intake (ADI). The residue) is: ADI for residues of total gonadotropins (i) Liver (the target tissue). 125 parts (human chorionic gonadotropin and per billion (ppb). pregnant mare serum gonadotropin) is (ii) Muscle. 25 ppb. 42.25 I.U. per kilogram of body weight (iii) Milk: 2 ppb 5-hydroxy flunixin. per day.

402

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00412 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 556.347

(b) Tolerances. A tolerance for resi- (b) Tolerances—(1) Liver. A tolerance dues of gonadotropin in uncooked edi- is established for 22,23- ble tissues of cattle or of fish is not re- dihydroavermectin B1a (marker res- quired. idue) in liver (target tissue) as follows: [64 FR 48545, Sept. 7, 1999] (i) Cattle. 1.6 parts per million. (ii) Swine. 20 parts per billion. § 556.308 Halofuginone hydrobromide. (iii) Sheep. 30 parts per billion. The marker residue selected to mon- (iv) Reindeer. 15 parts per billion. itor for total residues of halofuginone (v) American bison. 15 parts per bil- hydrobromide in broilers and turkeys lion. is parent halofuginone hydrobromide (2) Muscle. Muscle residues are not in- and the target tissue selected is liver. dicative of the safety of other edible A tolerance is established in broilers of tissues. A tolerance is established for 0.16 part per million and in turkeys of 22,23-dihydroavermectin B1a (marker 0.13 part per million for parent residue) in muscle as follows: halofuginone hydrobromide in liver. (i) Swine. 20 parts per billion. These marker residue concentrations (ii) Cattle. 650 parts per billion. in liver correspond to total residue (c) Related conditions of use. See concentrations of 0.3 part per million §§ 520.1192, 520.1195, 520.1197, 522.1192, in liver. The safe concentrations for 522.1193, 524.1193, and 558.300 of this total residues of halofuginone chapter. hydrobromide in the uncooked edible tissues of broilers and turkeys are 0.1 [63 FR 54352, Oct. 9, 1998, as amended at 64 FR part per million in muscle, 0.3 part per 26671, May 17, 1999; 79 FR 64117, Oct. 28, 2014] million in liver, and 0.2 part per mil- § 556.346 Laidlomycin. lion in skin with adhering fat. As used in this section, ‘‘tolerance’’ refers to a (a) Acceptable daily intake (ADI). The concentration of a marker residue in ADI for total residues of laidlomycin is the target tissue selected to monitor 7.5 micrograms per kilogram of body for total residues of the drug in the weight per day. target animal, and ‘‘safe concentra- (b) Tolerance. The tolerance for par- tions’’ refers to the concentrations of ent laidlomycin (the marker residue) total residues considered safe in edible in the liver (the target tissue) of cattle tissues. is 0.2 part per million (ppm). [54 FR 28052, July 5, 1989, as amended at 56 [68 FR 42590, July 18, 2003] FR 8711, Mar. 1, 1991; 57 FR 21209, May 19, 1992] § 556.347 Lasalocid. (a) Acceptable daily intake (ADI). The § 556.310 Haloxon. ADI for total residues of lasalocid is 10 A tolerance of 0.1 part per million is micrograms per kilogram of body established for negligible residues of weight per day. haloxon (3-chloro-7-hydroxy-4-methyl- (b) Tolerances—(1) Cattle. The toler- coumarin bis(2-chloroethyl) phosphate) ance for parent lasalocid (the marker in the edible tissues of cattle. residue) in liver (the target tissue) is [40 FR 13942, Mar. 27, 1975, as amended at 45 0.7 part per million (ppm). FR 10333, Feb. 15, 1980] (2) Chickens—(i) Skin with adhering fat (the target tissue). The tolerance for par- § 556.330 Hygromycin B. ent lasalocid (the marker residue) is 1.2 A tolerance of zero is established for ppm. residues of hygromycin B in or on eggs (ii) Liver. The tolerance for parent and the uncooked edible tissues of lasalocid (the marker residue) is 0.4 swine and poultry. ppm. (3) Turkeys—(i) Liver (the target tis- § 556.344 Ivermectin. sue). The tolerance for parent lasalocid (a) Acceptable Daily Intake (ADI). The (the marker residue) is 0.4 ppm. ADI for total residues of ivermectin is (ii) Skin with adhering fat. The toler- 5 micrograms per kilogram of body ance for parent lasalocid (the marker weight per day. residue) is 0.4 ppm.

403

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00413 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 556.350 21 CFR Ch. I (4–1–19 Edition)

(4) Rabbits. The tolerance for parent § 556.410 Metoserpate hydrochloride. lasalocid (the marker residue) in liver A tolerance of 0.02 part per million is (the target tissue) is 0.7 ppm. established for negligible residues of (5) Sheep. The tolerance for parent metoserpate hydrochloride (methyl-o- lasalocid (the marker residue) in liver methyl-18-epireserpate hydrochloride) (the target tissue) is 1.0 ppm. in uncooked edible tissues of chickens. [66 FR 19854, Apr. 18, 2001] § 556.420 Monensin. § 556.350 Levamisole hydrochloride. (a) Acceptable daily intake (ADI). The A tolerance of 0.1 part per million is ADI for total residues of monensin is established for negligible residues of 12.5 micrograms per kilogram of body levamisole hydrochloride in the edible weight per day. tissues of cattle, sheep, and swine. (b) Tolerances. The tolerances for residues of monensin are: § 556.360 Lincomycin. (1) Cattle—(i) Liver. 0.10 part per mil- (a) Acceptable daily intake (ADI). The lion (ppm). ADI for total residues of lincomycin is (ii) Muscle, kidney, and fat. 0.05 ppm. 25 micrograms per kilogram of body (iii) Milk. Not required. weight per day. (2) Goats—(i) Edible tissues. 0.05 ppm. (b) Chickens. A tolerance for residues (ii) [Reserved] of lincomycin in chickens is not re- (3) Chickens, turkeys, and quail. A tol- quired. erance for residues of monensin in (c) Swine. Tolerances for lincomycin chickens, turkeys, and quail is not re- of 0.6 part per million in liver and 0.1 quired. part per million in muscle are estab- (c) Related conditions of use. See lished. §§ 520.1448 and 558.355 of this chapter. [64 FR 13342, Mar. 18, 1999] [64 FR 5159, Feb. 3, 1999, as amended at 69 FR 68783, Nov. 26, 2004; 72 FR 56897, Oct. 5, 2007] § 556.375 Maduramicin ammonium. § 556.425 Morantel tartrate. A tolerance is established for residues of maduramicin ammonium in A tolerance of 0.7 part per million is chickens as follows: established for N-methyl-1,3- propanediamine (MAPA, marker res- (a) A tolerance for maduramicin am- idue) in the liver (target tissue) of cat- monium (marker residue) in chickens tle and goats. A tolerance for residues is 0.38 parts per million in fat (target of morantel tartrate in milk is not re- tissue). A tolerance refers to the con- quired. centration of marker residues in the target tissue used to monitor for total [59 FR 17922, Apr. 15, 1994] drug residues in the target animals. (b) The safe concentrations for total § 556.426 Moxidectin. maduramicin ammonium residues in (a) Acceptable daily intake (ADI). The uncooked edible chicken tissues are: ADI for total residues of moxidectin is 0.24 parts per million in muscle; 0.72 4 micrograms per kilogram of body parts per million in liver; 0.48 parts per weight per day. million in skin; and 0.48 parts per mil- (b) Tolerances—(1) Cattle—(i) Fat (the lion in fat. A safe concentration refers target tissue). The tolerance for parent to the total residue concentration con- moxidectin (the marker residue) is 900 sidered safe in edible tissues. parts per billion (ppb). [54 FR 5229, Feb. 2, 1989] (ii) Liver. The tolerance for parent moxidectin (the marker residue) is 200 § 556.380 Melengestrol acetate. ppb. (iii) Muscle. The tolerance for parent A tolerance of 25 parts per billion is moxidectin (the marker residue) is 50 established for residues of the parent ppb. compound, melengestrol acetate, in fat (iv) Milk. The tolerance for parent of cattle. moxidectin (the marker residue) is 40 [59 FR 41241, Aug. 11, 1994] ppb.

404

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00414 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 556.495

(2) Sheep—(i) Fat (the target tissue). (b) Tolerance. The tolerance for 4,4′- The tolerance for parent moxidectin dinitrocarbanilide (marker residue) is: (the marker residue) is 900 parts per (1) Chickens—Liver (target tissue): 52 billion (ppb). ppm. (ii) Liver. The tolerance for parent (2) [Reserved] moxidectin (the marker residue) is 200 (c) Related conditions of use. See ppb. §§ 558.364 and 558.366 of this chapter. (iii) Muscle. The tolerance for parent moxidectin (the marker residue) is 50 [83 FR 64741, Dec. 18, 2018, as amended at 84 ppb. FR 8974, Mar. 13, 2019] (c) Related conditions of use. See § 556.460 Novobiocin. §§ 520.1454 and 522.1450 of this chapter. Tolerances for residues of novobiocin [65 FR 36617, June 9, 2000, as amended at 65 are established at 0.1 part per million FR 76930, Dec. 8, 2000; 70 FR 36338, June 23, 2005; 70 FR 76163, Dec. 23, 2005] in milk from dairy animals and 1 part per million in the uncooked edible tis- § 556.428 Narasin. sues of cattle, chickens, turkeys, and (a) Acceptable daily intake (ADI). The ducks. ADI for total residues of narasin is 5 [47 FR 18590, Apr. 30, 1982] micrograms per kilogram of body weight per day. § 556.470 Nystatin. (b) Tolerances—(1) Chickens (abdominal A tolerance of zero is established for fat). The tolerance for parent narasin residues of nystatin in or on eggs and (the marker residue) is 480 parts per the uncooked edible tissues of swine billion. and poultry. (2) [Reserved] (c) Related conditions of use. See § 556.490 Ormetoprim. §§ 558.363 and 558.364 of this chapter. (a) [Reserved] [66 FR 23589, May 9, 2001, as amended at 83 (b) Tolerances. A tolerance of 0.1 part FR 64741, Dec. 18, 2018] per million (ppm) is established for negligible residues of ormetoprim in § 556.430 Neomycin. uncooked edible tissues of chickens, (a) Acceptable daily intake (ADI). The turkeys, ducks, salmonids, catfish, and ADI for total residues of neomycin is 6 chukar partridges. micrograms per kilogram of body weight per day. [64 FR 26672, May 17, 1999] (b) Tolerances. Tolerances are established for residues of parent neomycin § 556.495 Oxfendazole. in uncooked edible tissues as follows: Cattle: A tolerance is established for (1) Cattle, swine, sheep, and goats. 7.2 total oxfendazole residues in edible parts per million (ppm) in kidney (tar- cattle tissues based on a marker res- get tissue) and fat, 3.6 ppm in liver, and idue concentration of 0.8 part per mil- 1.2 ppm in muscle. lion (ppm) fenbendazole in the target (2) Turkeys. 7.2 ppm in skin with liver tissue. A fenbendazole concentra- adhearing fat, 3.6 ppm in liver, and 1.2 tion of 0.8 ppm in liver corresponds to ppm in muscle. a total safe concentration of (3) Milk. A tolerance is established oxfendazole residues of 1.7 ppm in liver. for residues of parent neomycin of 0.15 The safe concentrations of total ppm. oxfendazole residues in other uncooked edible cattle tissues are: muscle, 0.84 [64 FR 31498, June 11, 1999] ppm; kidney, 2.5 ppm; and fat, 3.3 ppm. § 556.445 Nicarbazin. A tolerance refers to the concentration of marker residue in the target tissue (a) Acceptable daily intake (ADI). The selected to monitor for total drug res- ADI for total residues of nicarbazin idue in the target animal. A safe con- (4,4′-dinitrocarbanilide and 2-hydroxy- centration is the total residue consid- 4,6-dimethylpyrimidine) is 200 ered safe in edible tissue. micrograms per kilogram of body weight per day. [55 FR 46943, Nov. 8, 1990]

405

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00415 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 556.500 21 CFR Ch. I (4–1–19 Edition)

§ 556.500 Oxytetracycline. (iii) Milk. The tolerance for parent (a) Acceptable daily intake (ADI). The pirlimycin (the marker residue in cat- ADI for total tetracycline residues tle milk) is 0.4 ppm. (chlortetracycline, oxytetracycline, (2) [Reserved] and tetracycline) is 25 micrograms per [65 FR 61091, Oct. 16, 2000] kilogram of body weight per day. (b) Beef cattle, dairy cattle, calves, § 556.540 Progesterone. swine, sheep, chickens, turkeys, finfish, (a) [Reserved] and lobster. Tolerances are established for the sum of residues of the (b) Tolerances. Residues of progester- tetracyclines including chlortetra- one are not permitted in excess of the cycline, oxytetracycline, and tetra- following increments above the con- cycline, in tissues and milk as follows: centrations of progesterone naturally (1) 2 parts per million (ppm) in mus- present in untreated animals: cle. (1) Cattle and sheep—(i) Muscle: 5 (2) 6 ppm in liver. parts per billion (ppb). (3) 12 ppm in fat and kidney. (ii) Liver: 15 ppb. (4) 0.3 ppm in milk. (iii) Kidney: 30 ppb. [63 FR 57246, Oct. 27, 1998, as amended at 66 (iv) Fat: 30 ppb. FR 46370, Sept. 5, 2001; 69 FR 6557, Feb. 11, (2) [Reserved] 2004] (c) Related conditions of use. See §§ 522.1940 and 529.1940 of this chapter. § 556.510 Penicillin. Tolerances are established for resi- [76 FR 57907, Sept. 19, 2011] dues of penicillin and the salts of peni- § 556.560 Pyrantel tartrate. cillin in food as follows: (a) 0.05 part per million (negligible Tolerances are established for resi- residue) in the uncooked edible tissues dues of pyrantel tartrate in edible tis- of cattle. sues of swine as follows: (b) Zero in the uncooked edible tis- (a) 10 parts per million in liver and sues of chickens, pheasants, quail, kidney. swine, and sheep; in eggs; and in milk (b) 1 part per million in muscle. or in any processed food in which such milk has been used. § 556.570 Ractopamine. (c) 0.01 part per million in the (a) Acceptable Daily Intake (ADI). The uncooked edible tissues of turkeys. ADI for total residues of ractopamine [40 FR 13942, Mar. 27, 1975, as amended at 43 hydrochloride is 1.25 micrograms per FR 32749, July 28, 1978] kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver § 556.513 Piperazine. (the target tissue). The tolerance for A tolerance of 0.1 part per million pi- ractopamine hydrochloride (the mark- perazine base is established for edible er residue) is 0.09 parts per million tissues of poultry and swine. (ppm). [64 FR 23019, Apr. 29, 1999] (ii) Muscle. The tolerance for ractopamine hydrochloride (the mark- § 556.515 Pirlimycin. er residue) is 0.03 ppm. (a) Acceptable daily intake (ADI). The (2) Swine—(i) Liver (the target tissue). ADI for total residues of pirlimycin is The tolerance for ractopamine hydro- 0.01 milligrams per kilogram of body chloride (the marker residue) is 0.15 weight per day. ppm. (b) Tolerances—(1) Cattle—(i) Liver (ii) Muscle. The tolerance for (the target tissue). The tolerance for par- ractopamine hydrochloride (the mark- ent pirlimycin (the marker residue) is er residue) is 0.05 ppm. 0.5 part per million (ppm). (3) Turkeys—(i) Liver (the target tis- (ii) Muscle. The tolerance for parent sue). The tolerance for ractopamine pirlimycin (the marker residue) is 0.3 (the marker residue) is 0.45 ppm. ppm.

406

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00416 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 556.650

(ii) Muscle. The tolerance for § 556.610 Streptomycin. ractopamine (the marker residue) is 0.1 Tolerances are established for resi- ppm. dues of streptomycin in uncooked, edi- [68 FR 54659, Sept. 18, 2003, as amended at 73 ble tissues of chickens, swine, and FR 72715, Dec. 1, 2008] calves of 2.0 parts per million (ppm) in kidney and 0.5 ppm in other tissues. § 556.580 Robenidine hydrochloride. [58 FR 47211, Sept. 8, 1993] Tolerances are established for residues of robenidine hydrochloride in ed- § 556.620 Sulfabromomethazine so- ible tissues of chickens as follows: dium. (a) 0.2 part per million in skin and Tolerances for residues of fat. sulfabromomethazine sodium in food (b) 0.1 part per million (negligible are established as follows: residue) in edible tissues other than (a) In the uncooked edible tissues of skin and fat. cattle at 0.1 part per million (negligible residue). § 556.592 Salinomycin. (b) In milk at 0.01 part per million (a) Acceptable daily intake (ADI). The (negligible residue). ADI for total residues of salinomycin is [47 FR 30244, July 13, 1982] 0.005 milligram per kilogram of body weight per day. § 556.625 Sodium sulfachloropyrazine (b) [Reserved] monohydrate. [65 FR 70791, Nov. 28, 2000] A tolerance of zero is established for residues of sodium sulfachloropyrazine § 556.597 Semduramicin. monohydrate in the uncooked edible tissues of chickens. (a) Acceptable daily intake (ADI). The ADI for total residues of semduramicin § 556.630 Sulfachlorpyridazine. is 180 micrograms per kilogram of body weight per day. A tolerance of 0.1 part per million is (b) Tolerances—(1) Broiler chickens. established for negligible residues of Tolerances are established for residues sulfachlorpyridazine in uncooked edi- of parent semduramicin in uncooked ble tissues of calves and swine. edible tissues of 400 parts per billion § 556.640 Sulfadimethoxine. (ppb) in liver and 130 ppb in muscle. (2) [Reserved] (a) [Reserved] (b) Tolerances. (1) A tolerance of 0.1 [64 FR 48296, Sept. 3, 1999] part per million (ppm) is established for negligible residues of § 556.600 Spectinomycin. sulfadimethoxine in uncooked edible (a) Acceptable daily intake (ADI). The tissues of chickens, turkeys, cattle, ADI for total residues of spectinomycin ducks, salmonids, catfish, and chukar is 25 micrograms per kilogram of body partridges. weight per day. (2) A tolerance of 0.01 ppm is estab- (b) Chickens and turkeys. A tolerance lished for negligible residues of of 0.1 part per million (ppm) for neg- sulfadimethoxine in milk. ligible residues of spectinomycin in [64 FR 26672, May 17, 1999] uncooked edible tissues of chickens and turkeys is established. § 556.650 Sulfaethoxypyridazine. (c) Cattle. A tolerance of 4 ppm for Tolerances for residues of parent spectinomycin (marker residue) sulfaethoxypyridazine in food are es- in kidney (target tissue) is established. tablished as follows: A tolerance of 0.25 ppm for parent (a) Zero in the uncooked edible tis- spectinomycin in cattle muscle is es- sues of swine and in milk. tablished. (b) 0.1 part per million (negligible [63 FR 24107, May 1, 1998; 63 FR 38304, July 16, residue) in uncooked edible tissues of 1998] cattle.

407

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00417 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 556.660 21 CFR Ch. I (4–1–19 Edition)

§ 556.660 Sulfamerazine. million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kidney. A tolerance of zero is established for residues of sulfamerazine (N1-[4-meth- [63 FR 57246, Oct. 27, 1998] yl-2-pyrimidinyl]sulfanilamide) in the uncooked edible tissues of trout. § 556.730 Thiabendazole. Tolerances are established at 0.1 part § 556.670 Sulfamethazine. per million for negligible residues of A tolerance of 0.1 part per million is thiabendazole in uncooked edible tis- established for negligible residues of sues of cattle, goats, sheep, pheasants, sulfamethazine in the uncooked edible and swine, and at 0.05 part per million tissues of chickens, turkeys, cattle, for negligible residues in milk. and swine. [40 FR 13942, Mar. 27, 1975, as amended at 49 [47 FR 25323, June 11, 1982] FR 29958, July 25, 1984]

§ 556.685 Sulfaquinoxaline. § 556.732 Tiamulin. A tolerance of 0.1 part per million is A tolerance of 0.6 part per million is established for negligible residues of established for 8-alpha-hydroxymutilin sulfaquinoxaline in the uncooked edi- (marker compound) in liver (target tis- ble tissues of chickens, turkeys, calves, sue) of swine. and cattle. [62 FR 12086, Mar. 14, 1997. Redesignated at 80 FR 13230, Mar. 13, 2015] [61 FR 24443, May 15, 1996]

§ 556.700 Sulfomyxin. § 556.733 Tildipirosin. (a) Acceptable Daily Intake (ADI). The A tolerance of zero is established for ADI for total residues of tildipirosin is residues of sulfomyxin (N-sulfomethyl- 50 micrograms per kilogram of body polymyxin B sodium salt) in uncooked weight per day. edible tissues from chickens and turkeys. (b) Tolerances. The tolerances for tildipirosin (the marker residue) are: § 556.710 Testosterone propionate. (1) Cattle—(i) Liver (the target tissue): 10 parts per million. No residues of testosterone, resulting (ii) [Reserved] from the use of testosterone propio- (2) [Reserved] nate, are permitted in excess of the fol- (c) See lowing increments above the con- Related conditions of use. § 522.2460 of this chapter. centrations of testosterone naturally present in untreated animals: [77 FR 39391, July 3, 2012, as amended at 78 (a) In uncooked edible tissues of heif- FR 52854, Aug. 27, 2013] ers: (1) 0.64 part per billion in muscle. § 556.735 Tilmicosin. (2) 2.6 parts per billion in fat. (a) Acceptable daily intake (ADI). The (3) 1.9 parts per billion in kidney. ADI for total residues of tilmicosin is (4) 1.3 parts per billion in liver. 25 micrograms per kilogram of body (b) [Reserved] weight per day. (b) Tolerances—(1) Cattle—(i) Liver [52 FR 27683, July 23, 1987] (the target tissue). The tolerance for parent tilmicosin (the marker residue) is § 556.720 Tetracycline. 1.2 parts per million (ppm). (a) Acceptable daily intake (ADI). The (ii) Muscle. The tolerance for parent ADI for total tetracycline residues tilmicosin (the marker residue) is 0.1 (chlortetracycline, oxytetracycline, ppm. and tetracycline) is 25 micrograms per (2) Swine—(i) Liver (the target tissue). kilogram of body weight per day. The tolerance for parent tilmicosin (b) Tolerances. Tolerances are estab- (the marker residue) is 7.5 ppm. lished for the sum of tetracycline resi- (ii) Muscle. The tolerance for parent dues in tissues of calves, swine, sheep, tilmicosin (the marker residue) is 0.1 chickens, and turkeys, of 2 parts per ppm.

408

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00418 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 556.765

(3) Sheep—(i) Liver (the target tissue). (2) Swine—(i) Kidney (the target tis- The tolerance for parent tilmicosin sue). The tolerance for CP–60,300 (the (the marker residue) is 1.2 ppm. marker residue) is 15 ppm. (ii) Muscle. The tolerance for parent (ii) [Reserved] tilmicosin (the marker residue) is 0.1 (c) Related conditions of use. See ppm. § 522.2630 of this chapter. [64 FR 13679, Mar. 22, 1999, as amended at 67 [70 FR 39918, July 12, 2005] FR 72368, Dec. 5, 2002; 78 FR 52854, Aug. 27, 2013] § 556.748 Tylvalosin. (a) Acceptable Daily Intake (ADI). The § 556.739 Trenbolone. ADI for total residues of tylvalosin is (a) Acceptable daily intake (ADI). The 47.7 micrograms per kilogram of body ADI for total residues of trenbolone is weight per day. 0.4 microgram per kilogram of body (b) Tolerances. A tolerance for weight per day. tylvalosin in edible tissues of swine is (b) Tolerances. A tolerance for total not required. trenbolone residues in uncooked edible (c) Related conditions of use. See tissues of cattle is not needed. §§ 520.2645 and 558.633 of this chapter. [64 FR 18574, Apr. 15, 1999] [77 FR 55415, Sept. 10, 2012, as amended at 81 FR 36789, June 8, 2016] § 556.740 Tylosin. § 556.750 Virginiamycin. Tolerances are established for residues of tylosin in edible products of (a) Acceptable daily intake (ADI). The animals as follows: ADI for total residues of virginiamycin is 250 micrograms per kilogram of body (a) In chickens and turkeys: 0.2 part weight per day. per million (negligible residue) in (b) Tolerances—(1) Swine. Tolerances uncooked fat, muscle, liver, and kid- are established for residues of ney. virginiamycin in uncooked edible tis- (b) In cattle: 0.2 part per million sues of 0.4 part per million (ppm) in (negligible residue) in uncooked fat, kidney, skin, and fat, 0.3 ppm in liver, muscle, liver, and kidney. and 0.1 ppm in muscle. (c) In swine: 0.2 part per million (neg- (2) Broiler chickens and cattle. A toler- ligible residue) in uncooked fat, mus- ance for residues of virginiamycin is cle, liver, and kidney. not required. (d) In milk: 0.05 part per million (negligible residue). [64 FR 48296, Sept. 3, 1999] (e) In eggs: 0.2 part per million (neg- § 556.760 Zeranol. ligible residue). (a) Acceptable daily intake (ADI). The § 556.741 Tripelennamine. ADI for total residues of zeranol is 0.00125 milligrams per kilogram of body A tolerance of 200 parts per billion weight per day. (ppb) is established for residues of (b) The tolerances for res- tripelennamine in uncooked edible tis- Tolerances. idues of zeranol in edible tissues are: sues of cattle and 20 ppb in milk. (1) Cattle. A tolerance is not needed. [62 FR 4164, Jan. 29, 1997] (2) Sheep. 20 parts per billion. (c) Related conditions of use. See § 556.745 Tulathromycin. § 522.2680 of this chapter. (a) Acceptable daily intake (ADI). The [40 FR 13942, Mar. 27, 1975, as amended at 54 ADI for total residues of tulathromycin FR 31950, Aug. 3, 1989; 67 FR 6867, Feb. 14, is 15 micrograms per kilogram of body 2002; 70 FR 15759, Mar. 29, 2005] weight per day. (b) Tolerances—(1) Cattle—(i) Liver § 556.765 Zilpaterol. (the target tissue). The tolerance for CP– (a) Acceptable daily intake (ADI). The 60,300 (the marker residue) is 5.5 parts ADI for total residues of zilpaterol is per million (ppm). 0.083 micrograms per kilogram of body (ii) [Reserved] weight per day.

409

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00419 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 556.770 21 CFR Ch. I (4–1–19 Edition)

(b) Tolerances—(1) Cattle—(i) Liver 558.235 Efrotomycin. (the target tissue). The tolerance for 558.248 Erythromycin. zilpaterol (the marker residue) is 12 558.254 Famphur. parts per billion (ppb). 558.258 Fenbendazole. 558.261 Florfenicol. (ii) Muscle. The tolerance for 558.265 Halofuginone hydrobromide. zilpaterol (the marker residue) is 10 558.274 Hygromycin B. ppb. 558.295 Iodinated casein. (2) [Reserved] 558.300 Ivermectin. (c) Related conditions of use. See 558.305 Laidlomycin. § 558.665 of this chapter. 558.311 Lasalocid. 558.325 Lincomycin. [71 FR 53005, Sept. 8, 2006, as amended at 81 558.340 Maduramicin. FR 17608, Mar. 30, 2016] 558.342 Melengestrol. 558.348 Mibolerone. § 556.770 Zoalene. 558.355 Monensin. Tolerances are established for resi- 558.360 Morantel tartrate. dues of zoalene (3,5-dinitro-o- 558.363 Narasin. toluamide) and its metabolite 3-amino- 558.364 Narasin and nicarbazin. 5-nitro-o-toluamide in food as follows: 558.365 Neomycin sulfate. (a) In edible tissues of chickens: 558.366 Nicarbazin. 558.415 Novobiocin. (1) 6 parts per million in uncooked 558.430 Nystatin. liver and kidney. 558.450 Oxytetracycline. (2) 3 parts per million in uncooked 558.455 Oxytetracycline and neomycin. muscle tissue. 558.464 Poloxalene. (3) 2 parts per million in uncooked 558.465 Poloxalene free-choice liquid Type C fat. feed. (b) In edible tissues of turkeys: 3 558.485 Pyrantel. parts per million in uncooked muscle 558.500 Ractopamine. tissue and liver. 558.515 Robenidine. 558.550 Salinomycin. 558.555 Semduramicin. PART 558—NEW ANIMAL DRUGS 558.575 Sulfadimethoxine and ormetoprim. FOR USE IN ANIMAL FEEDS 558.582 Sulfamerazine. 558.586 Sulfaquinoxaline. Subpart A—General Provisions 558.600 Thiabendazole. 558.612 Tiamulin. Sec. 558.618 Tilmicosin. 558.3 Definitions and general considerations 558.625 Tylosin. applicable to this part. 558.630 Tylosin and sulfamethazine. 558.4 Requirement of a medicated feed mill 558.633 Tylvalosin. license. 558.635 Virginiamycin. 558.5 Requirements for liquid medicated 558.665 Zilpaterol. feed. 558.680 Zoalene. 558.6 Veterinary feed directive drugs. AUTHORITY: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. Subpart B—Specific New Animal Drugs For Use in Animal Feeds SOURCE: 40 FR 13959, Mar. 27, 1975, unless otherwise noted. 558.55 Amprolium. 558.58 Amprolium and ethopabate. 558.59 Apramycin. Subpart A—General Provisions 558.68 Avilamycin. 558.76 Bacitracin methylenedisalicylate. § 558.3 Definitions and general consid- 558.78 Bacitracin zinc. erations applicable to this part. 558.95 Bambermycins. (a) Regulations in this part provide 558.115 Carbadox. for approved uses of drugs and com- 558.128 Chlortetracycline. binations of drugs in animal feeds. Ap- 558.140 Chlortetracycline and proved combinations of such drugs are sulfamethazine. specifically identified or incorporated 558.175 Clopidol. 558.185 Coumaphos. by cross-reference. Unless specifically 558.195 Decoquinate. provided for by the regulations, a com- 558.198 Diclazuril. bination of two or more drugs is not 558.205 Dichlorvos. approved.

410

VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00420 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB