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353 Part 556—Tolerances for Resi- Dues Of Food and Drug Administration, HHS Pt. 556 (4) Dimetridazole; 556.70 Bacitracin. (5) Ipronidazole; 556.100 Carbadox. (6) Other nitroimidazoles; 556.110 Carbomycin. (7) Furazolidone. 556.113 Ceftiofur. 556.115 Cephapirin. (8) Nitrofurazone. 556.118 Chloramine-T. (9) Sulfonamide drugs in lactating 556.120 Chlorhexidine. dairy cattle (except approved use of 556.150 Chlortetracycline. sulfadimethoxine, 556.160 Clopidol. sulfabromomethazine, and 556.163 Clorsulon. sulfaethoxypyridazine); 556.165 Cloxacillin. (10) Fluoroquinolones; and 556.167 Colistimethate. (11) Glycopeptides. 556.169 Danofloxacin. 556.170 Decoquinate. (12) Phenylbutazone in female dairy 556.180 Dichlorvos. cattle 20 months of age or older. 556.185 Diclazuril. (13) Cephalosporins (not including 556.200 Dihydrostreptomycin. cephapirin) in cattle, swine, chickens, 556.225 Doramectin. or turkeys: 556.226 Enrofloxacin. (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. 556.260 Ethopabate. or 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. 556.304 Gonadotropin. [Reserved] 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. 556.375 Maduramicin ammonium. (2) Neuraminidase inhibitors. 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- 556.440 Nequinate. DUES OF NEW ANIMAL DRUGS IN 556.445 Nicarbazin. FOOD 556.460 Novobiocin. 556.470 Nystatin. Subpart A—General Provisions 556.480 Oleandomycin. 556.490 Ormetoprim. Sec. 556.495 Oxfendazole. 556.1 General considerations; tolerances for 556.500 Oxytetracycline. residues of new animal drugs in food. 556.510 Penicillin. 556.513 Piperazine. Subpart B—Specific Tolerances for 556.515 Pirlimycin. Residues of New Animal Drugs 556.540 Progesterone. 556.560 Pyrantel tartrate. 556.34 Albendazole. 556.570 Ractopamine. 556.36 Altrenogest. 556.580 Robenidine hydrochloride. 556.38 Amoxicillin. 556.592 Salinomycin. 556.40 Ampicillin. 556.597 Semduramicin. 556.50 Amprolium. 556.600 Spectinomycin. 556.52 Apramycin. 556.610 Streptomycin. 556.60 Arsenic. 556.620 Sulfabromomethazine sodium. 353 VerDate Sep<11>2014 16:01 May 14, 2015 Jkt 235075 PO 00000 Frm 00363 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB § 556.1 21 CFR Ch. I (4–1–15 Edition) 556.625 Sodium sulfachloropyrazine animal—in which case the accepted monohydrate. method of analysis shall be published 556.630 Sulfachlorpyridazine. or cited, if previously published and 556.640 Sulfadimethoxine. 556.650 Sulfaethoxypyridazine. available elsewhere, in this part; or 556.660 Sulfamerazine. (4) It may or may not be possible to 556.670 Sulfamethazine. determine whether finite residues will 556.685 Sulfaquinoxaline. be incurred but there is no reasonable 556.690 Sulfathiazole. expectation that they may be present— 556.700 Sulfomyxin. 556.710 Testosterone propionate. in which case the establishment of a 556.720 Tetracycline. tolerance is not required; or 556.730 Thiabendazole. (5) The drug is such that it may be 556.732 Tiamulin. metabolized and/or assimilated in such 556.733 Tildipirosin. form that any possible residue would 556.735 Tilmicosin. be indistinguishable from normal tis- 556.739 Trenbolone. 556.740 Tylosin. sue constituents—in which case the es- 556.741 Tripelennamine. tablishment of a tolerance is not re- 556.745 Tulathromycin. quired. 556.748 Tylvalosin. (b) No tolerance established pursuant 556.750 Virginiamycin. to paragraph (a)(1) of this section will 556.760 Zeranol. 556.765 Zilpaterol. be set at any level higher than that re- 556.770 Zoalene. flected by the permitted use of the 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 drugs in food. established tolerance level or, in cer- 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: (1) Finite residues will be present in Subpart B—Specific Tolerances for the edible products—in which case a fi- Residues of New Animal Drugs nite tolerance is required; or (2) It is not possible to determine § 556.34 Albendazole. whether finite residues will be incurred (a) Acceptable daily intake (ADI). The but there is reasonable expectation ADI for total residues of albendazole is that they may be present—in which 5 micrograms per kilogram of body case a tolerance for negligible residue weight per day. is required; or (b) Tolerances. The tolerances for (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) —(i) : 0.2 tion of the safety of such drug, has Cattle Liver (target tissue) parts per million (ppm). been shown to induce cancer in man or animal; however, such drug will not ad- (ii) Muscle: 0.05 ppm. versely affect the animals for which it (2) Sheep—(i) Liver (target tissue): 0.25 is intended, and no residue of such drug ppm. will be found by prescribed methods of (ii) Muscle: 0.05 ppm. analysis in any edible portion of such (3) Goat—(i) Liver (target tissue): 0.25 animals after slaughter or in any food ppm. yielded by or derived from the living (ii) [Reserved] 354 VerDate Sep<11>2014 16:01 May 14, 2015 Jkt 235075 PO 00000 Frm 00364 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB Food and Drug Administration, HHS § 556.113 (c) Related conditions of use. See (2) 0.5 part per million in uncooked § 520.45 of this chapter. muscle. [64 FR 1504, Jan. 11, 1999, as amended at 73 [40 FR 13942, Mar. 27, 1975, as amended at 50 FR 11027, Feb. 29, 2008] FR 18472, May 1, 1985] § 556.36 Altrenogest. § 556.52 Apramycin. (a) Acceptable Daily Intake (ADI). The A tolerance of 0.1 part per million is ADI for total residues of altrenogest is established for parent apramycin 0.04 micrograms per kilogram of body (marker residue) in kidney (target tis- sue) of swine. The acceptable daily in- weight per day. take (ADI) for total residues of (b) Tolerances—(1) Swine—(i) Liver (the apramycin is 25 micrograms per kilo- target tissue). The tolerance for gram of body weight per day. altrenogest (the marker residue) is 4 parts per billion (ppb). [62 FR 40933, July 31, 1997] (ii) Muscle. The tolerance for § 556.60 Arsenic. altrenogest (the marker residue) is 1 ppb. (a) [Reserved] (2) [Reserved] (b) Tolerances. The tolerances for total residue of combined arsenic (cal- [68 FR 62007, Oct. 31, 2003] culated as As) are: (1) Turkeys—(i) Muscle and eggs: 0.5 § 556.38 Amoxicillin. parts per million (ppm). A tolerance of 0.01 part per million is (ii) Other edible tissues: 2 ppm. established for negligible residues of (2) [Reserved] amoxicillin in milk and in the (c) Related conditions of use. See uncooked edible tissues of cattle. § 558.369 of this chapter. [79 FR 10979, Feb. 27, 2014] [49 FR 45422, Nov. 16, 1984] § 556.70 Bacitracin. § 556.40 Ampicillin. (a) Acceptable daily intake (ADI). The A tolerance of 0.01 p/m is established ADI for total residues of bacitracin is for negligible residues of ampicillin in 0.05 milligram per kilogram of body the uncooked edible tissues of swine weight per day. and cattle and in milk. (b) Tolerances. The tolerance for resi- dues of bacitracin from zinc bacitracin § 556.50 Amprolium. or bacitracin methylene disalicylate in Tolerances are established as follows uncooked edible tissues of cattle, for residues of amprolium (1-(4-amino- swine, chickens, turkeys, pheasants, 2-n- propyl-5-pyrimidinylmethyl)-2- and quail, and in milk and eggs is 0.5 picolinium chloride hydrochloride): part per million. (a) In the edible tissues and in eggs of [65 FR 70791, Nov. 28, 2000] chickens and turkeys: (1) 1 part per million in uncooked § 556.100 Carbadox. liver and kidney. A tolerance of 30 parts per billion is (2) 0.5 part per million in uncooked established for residues of quinoxaline- muscle tissue. 2-carboxylic acid (marker residue) in (3) In eggs: liver (target tissue) of swine. (i) 8 parts per million in egg yolks.
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