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CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2016]
[CITE: 21CFR556]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
 
PART 556TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
 

Subpart A--General Provisions

Sec. 556.1 General considerations; tolerances 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 animals treated with such drugs. Consideration of an appropriate tolerance for a drug shall result in a conclusion either that:

(1) Finite residues will be present in the edible products--in which case a finite 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 ingested by man or animal or, after tests which are appropriate for the evaluation of the safety of such drug, has been shown to induce cancer in man or animal; however, such drug will not adversely 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 tissue constituents--in which case the establishment of a tolerance is not required.

(b) No tolerance established pursuant to paragraph (a)(1) of this section will be set at any level higher than that reflected by the permitted use of the drug.

(c) Any tolerance required pursuant to this section will, in addition to the toxicological considerations, be conditioned on the availability of a practicable analytical method to determine the quantity of residue. Such method must be sensitive to and reliable at the established tolerance level or, in certain 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 exceeding the tolerance.

Subpart B--Specific Tolerances for Residues of New Animal Drugs

Sec. 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.

Sec. 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]

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 556.52 Apramycin.

A tolerance of 0.1 part per million is established for parent apramycin (marker residue) in kidney (target tissue) of swine. The acceptable daily intake (ADI) for total residues of apramycin is 25 micrograms per kilogram of body weight per day.

Sec. 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.

Sec. 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 residues 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.

Sec. 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.

Sec. 556.110 Carbomycin.

A tolerance of zero is established for residues of carbomycin in the uncooked edible tissues of chickens.

Sec. 556.113 Ceftiofur.

(a) Acceptable daily intake and acceptable 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 kilogram of body weight. The ASDI is the amount of total residues of ceftiofur that may safely be consumed in a single 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.

Sec. 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.

Sec. 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 residue) is 0.90 parts per million.

(ii) [Reserved]

(2) [Reserved]

(c) Related conditions of use. See 529.382 of this chapter.

Sec. 556.120 Chlorhexidine.

A tolerance of zero is established for residues of chlorhexidine in the uncooked edible tissues of calves.

Sec. 556.150 Chlortetracycline.

(a) Acceptable daily intake (ADI). The ADI for total residues of tetracyclines including chlortetracycline, oxytetracycline, and tetracycline is 25 micrograms per kilogram of body weight per day.

(b) Tolerances. (1) Tolerances are established for the sum of tetracycline residues in tissues of beef cattle, nonlactating 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 kidney.

(2) A tolerance is established for residues of chlortetracycline in eggs of 0.4 ppm.

Sec. 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 (negligible residue).

Sec. 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 parent 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]

Sec. 556.165 Cloxacillin.

A tolerance of 0.01 part per million is established for negligible residues of cloxacillin in the uncooked edible tissues of cattle and in milk.

Sec. 556.167 Colistimethate.

A tolerance for residues of colistimethate in the edible tissues of chickens is not required.

Sec. 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 parent 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]

Sec. 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 established for residues of decoquinate in the uncooked, edible tissues of chickens, cattle, and goats as follows:

(1) 1 part per million (ppm) in skeletal muscle.

(2) 2 ppm in other tissues.

Sec. 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.

Sec. 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 residue) 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.

Sec. 556.200 Dihydrostreptomycin.

Tolerances are established for residues 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 556.230 Erythromycin.

Tolerances for residues of erythromycin in food are established as follows:

(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.

Sec. 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 heifers, 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]

Sec. 556.260 Ethopabate.

Tolerance for residues of ethopabate converted to metaphenetidine are established in the edible tissues of chickens as follows:

(a) 1.5 parts per million in uncooked liver and kidney.

(b) 0.5 part per million in uncooked muscle.

Sec. 556.273 Famphur.

Tolerances are established for residues of famphur including its oxygen analog in or on meat, fat, or meat byproducts of cattle at 0.1 part per million.

Sec. 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 parent 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 3.2 ppm.

(ii) Muscle. The tolerance for parent fenbendazole (the marker residue) is 2 ppm.

(3) Chickens --(i) Liver (the target tissue). The tolerance for fenbendazole sulfone (the marker residue) is 5.2 ppm.

(ii) [Reserved]

(4) Turkeys --(i) Liver (the target tissue ). The tolerance for fenbendazole sulfone (the marker residue) is 6 ppm.

(ii) Muscle. The tolerance for fenbendazole sulfone (the marker residue) is 2 ppm.

(5) 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.

(c) Related conditions of use. See 520.905a, 520.905c, 520.905d, 520.905e, and 558.258 of this chapter.

Sec. 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 "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 concentrations" refer to the concentrations of total residues considered safe in edible tissues.

Sec. 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 tolerance for florfenicol amine (the marker residue) in muscle/skin (the target tissues) 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.

Sec. 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 tolerance 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.

Sec. 556.292 Gamithromycin.

(a) Acceptable Daily Intake (ADI). The ADI for total residues of 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.

Sec. 556.300 Gentamicin sulfate.

(a) A tolerance of 0.1 part per million is established for negligible residues of gentamicin sulfate in the uncooked edible 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 determinative procedure and an HPLC confirmatory 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 concentration of 0.4 ppm in kidney corresponds to 0.4 ppm of total residue.

Sec. 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 residues of gonadotropin in uncooked edible tissues of cattle or of fish is not required.

Sec. 556.308 Halofuginone hydrobromide.

The marker residue selected to monitor 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 million 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 concentrations" refers to the concentrations of total residues considered safe in edible tissues.

Sec. 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.

Sec. 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.

Sec. 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 residue) 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 billion.

(2) Muscle. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows:

(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.

Sec. 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 parent laidlomycin (the marker residue) in the liver (the target tissue) of cattle is 0.2 part per million (ppm).

Sec. 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 tolerance 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 parent 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 tissue). The tolerance for parent lasalocid (the marker residue) is 0.4 ppm.

(ii) Skin with adhering fat. The tolerance 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.

Sec. 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.

Sec. 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 required.

(c) Swine. Tolerances for lincomycin of 0.6 part per million in liver and 0.1 part per million in muscle are established.

Sec. 556.375 Maduramicin ammonium.

A tolerance is established for residues of maduramicin ammonium in chickens as follows:

(a) A tolerance for maduramicin ammonium (marker residue) in chickens is 0.38 parts per million in fat (target tissue). A tolerance refers to the concentration 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 million in fat. A safe concentration refers to the total residue concentration considered safe in edible tissues.

Sec. 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.

Sec. 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.

Sec. 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 residues of monensin are:

(1) Cattle --(i) Liver. 0.10 part per million (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 tolerance for residues of monensin in chickens, turkeys, and quail is not required.

(c) Related conditions of use. See 520.1448 and 558.355 of this chapter.

Sec. 556.425 Morantel tartrate.

A tolerance of 0.7 part per million is established for N -methyl-1,3-propanediamine (MAPA, marker residue) in the liver (target tissue) of cattle and goats. A tolerance for residues of morantel tartrate in milk is not required.

Sec. 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.

Sec. 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]

Sec. 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 established 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 (target 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.

Sec. 556.440 Nequinate.

A tolerance of 0.1 part per million is established for negligible residues of nequinate in the uncooked edible tissues of chickens.

Sec. 556.445 Nicarbazin.

A tolerance of 4 parts per million is established for residues of nicarbazin in uncooked chicken muscle, liver, skin, and kidney.

Sec. 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 tissues of cattle, chickens, turkeys, and ducks.

Sec. 556.470 Nystatin.

A tolerance of zero is established for residues of nystatin in or on eggs and the uncooked edible tissues of swine and poultry.

Sec. 556.480 Oleandomycin.

Tolerances are established for negligible residues of oleandomycin in uncooked edible tissues of chickens, turkeys, and swine at 0.15 part per million.

Sec. 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.

Sec. 556.495 Oxfendazole.

Cattle: A tolerance is established for total oxfendazole residues in edible cattle tissues based on a marker residue concentration of 0.8 part per million (ppm) fenbendazole in the target liver tissue. A fenbendazole concentration 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 residue in the target animal. A safe concentration is the total residue considered safe in edible tissue.

Sec. 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 chlortetracycline, oxytetracycline, and tetracycline, in tissues and milk as follows:

(1) 2 parts per million (ppm) in muscle.

(2) 6 ppm in liver.

(3) 12 ppm in fat and kidney.

(4) 0.3 ppm in milk.

Sec. 556.510 Penicillin.

Tolerances are established for residues of penicillin and the salts of penicillin 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 tissues 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.

Sec. 556.513 Piperazine.

A tolerance of 0.1 part per million piperazine base is established for edible tissues of poultry and swine.

Sec. 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 parent 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 cattle milk) is 0.4 ppm.

(2) [Reserved]

Sec. 556.540 Progesterone.

(a) [Reserved]

(b) Tolerances. Residues of progesterone are not permitted in excess of the following increments above the concentrations of progesterone naturally present in untreated animals:

(1) Cattle and sheep --(i) Muscle: 5 parts per billion (ppb).

(ii) Liver: 15 ppb.

(iii) Kidney: 30 ppb.

(iv) Fat: 30 ppb.

(2) [Reserved]

(c) Related conditions of use. See 522.1940 and 529.1940 of this chapter.

Sec. 556.560 Pyrantel tartrate.

Tolerances are established for residues of pyrantel tartrate in edible tissues of swine as follows:

(a) 10 parts per million in liver and kidney.

(b) 1 part per million in muscle.

Sec. 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 marker residue) is 0.09 parts per million (ppm).

(ii) Muscle. The tolerance for ractopamine hydrochloride (the marker residue) is 0.03 ppm.

(2) Swine --(i) Liver (the target tissue). The tolerance for ractopamine hydrochloride (the marker residue) is 0.15 ppm.

(ii) Muscle. The tolerance for ractopamine hydrochloride (the marker residue) is 0.05 ppm.

(3) Turkeys --(i) Liver (the target tissue). The tolerance for ractopamine (the marker residue) is 0.45 ppm.

(ii) Muscle. The tolerance for ractopamine (the marker residue) is 0.1 ppm.

Sec. 556.580 Robenidine hydrochloride.

Tolerances are established for residues of robenidine hydrochloride in edible 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.

Sec. 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]

Sec. 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]

Sec. 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 negligible 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 established.

Sec. 556.610 Streptomycin.

Tolerances are established for residues of streptomycin in uncooked, edible tissues of chickens, swine, and calves of 2.0 parts per million (ppm) in kidney and 0.5 ppm in other tissues.

Sec. 556.620 Sulfabromomethazine sodium.

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).

Sec. 556.625 Sodium sulfachloropyrazine monohydrate.

A tolerance of zero is established for residues of sodium sulfachloropyrazine monohydrate in the uncooked edible tissues of chickens.

Sec. 556.630 Sulfachlorpyridazine.

A tolerance of 0.1 part per million is established for negligible residues of sulfachlorpyridazine in uncooked edible tissues of calves and swine.

Sec. 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 established for negligible residues of sulfadimethoxine in milk.

Sec. 556.650 Sulfaethoxypyridazine.

Tolerances for residues of sulfaethoxypyridazine in food are established as follows:

(a) Zero in the uncooked edible tissues of swine and in milk.

(b) 0.1 part per million (negligible residue) in uncooked edible tissues of cattle.

Sec. 556.660 Sulfamerazine.

A tolerance of zero is established for residues of sulfamerazine (N 1-[4-methyl-2-pyrimidinyl]sulfanilamide) in the uncooked edible tissues of trout.

Sec. 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.

Sec. 556.685 Sulfaquinoxaline.

A tolerance of 0.1 part per million is established for negligible residues of sulfaquinoxaline in the uncooked edible tissues of chickens, turkeys, calves, and cattle.

Sec. 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 turkeys.

Sec. 556.710 Testosterone propionate.

No residues of testosterone, resulting from the use of testosterone propionate, are permitted in excess of the following increments above the concentrations of testosterone naturally present in untreated animals:

(a) In uncooked edible tissues of heifers:

(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]

Sec. 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 established for the sum of tetracycline residues 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.

Sec. 556.730 Thiabendazole.

Tolerances are established at 0.1 part per million for negligible residues of thiabendazole in uncooked edible tissues of cattle, goats, sheep, pheasants, and swine, and at 0.05 part per million for negligible residues in milk.

Sec. 556.732 Tiamulin.

A tolerance of 0.6 part per million is established for 8-alpha -hydroxymutilin (marker compound) in liver (target tissue) of swine.

Sec. 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.

Sec. 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 parent 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.

Sec. 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.

Sec. 556.740 Tylosin.

Tolerances are established for residues 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 kidney.

(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 (negligible residue) in uncooked fat, muscle, liver, and kidney.

(d) In milk: 0.05 part per million (negligible residue).

(e) In eggs: 0.2 part per million (negligible residue).

Sec. 556.741 Tripelennamine.

A tolerance of 200 parts per billion (ppb) is established for residues of tripelennamine in uncooked edible tissues of cattle and 20 ppb in milk.

Sec. 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 tissue). 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.

Sec. 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 and 558.633 of this chapter.

Sec. 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 tissues 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 tolerance for residues of virginiamycin is not required.

Sec. 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 residues 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.

Sec. 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.

Sec. 556.770 Zoalene.

Tolerances are established for residues 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.

Authority: 21 U.S.C. 342, 360b, 371.
Source: 40 FR 13942, Mar. 27, 1975, unless otherwise noted.

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