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CFR Regulation

TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

Citation
21 CFR Part 556
Current through
Sections
106
§ 556.1Scope.

(a) The Federal Food, Drug, and Cosmetic Act requires an applicant seeking approval or conditional approval of a new animal drug to submit a proposed tolerance as part of its new animal drug application when such a tolerance is needed to assure that the proposed use of the new animal drug will be safe (see sections 512(b)(1)(H) and 571(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act). FDA assigns tolerances for animal drugs used in food-producing animals as part of the application approval process. Tolerances for approved and conditionally approved new animal drugs are codified in subpart B of this part.

(b) Compounds that have been found to be carcinogenic are regulated under subpart E of part 500 of this chapter.

§ 556.3Definitions.

As used in this part:

Acceptable daily intake (ADI) means the daily intake which, during up to an entire life of a human, appears to be without adverse effects or harm to the health of the consumer. The ADI most often will be set on the basis of the drug's toxicological, microbiological, or pharmacological properties. It is usually expressed in micrograms or milligrams of the chemical per kilogram of body weight per day.

Acute reference dose (ARfD) means an estimate of the amount of residues expressed on a body weight basis that can be ingested in a period of 24 hours or less without adverse effects or harm to the health of the human consumer.

Edible tissues means muscle, liver, kidney, fat, skin with fat in natural proportions, whole eggs, whole milk, and honey.

Marker residue means the residue whose concentration is in a known relationship to the concentration of total residue in an edible tissue.

mg/kg means milligrams per kilogram.

Not required, in reference to tolerances in this part, means that at the time of approval:

(1) No withdrawal period was necessary for residues of the drug to deplete to or below the concentrations considered to be safe, or an adequate withdrawal period was inherent in the proposed drug use, and there was a rapid depletion of residues, so there was no concern about residues resulting from misuse or overdosing; or

(2) No withdrawal period was necessary because the drug was poorly absorbed or metabolized rapidly so as to make selection of an analyte impractical or impossible.

ppb means parts per billion (equivalent to nanograms per gram (ng/g) or µg/kg).

ppm means parts per million (equivalent to micrograms per gram (µg/g) or mg/kg).

ppt means parts per trillion (equivalent to picograms per gram (pg/g) or nanograms per kilogram (ng/kg)).

Residue means any compound present in edible tissues that results from the use of a drug, and includes the drug, its metabolites, and any other substance formed in or on food because of the drug's use.

Target tissue means the edible tissue selected to monitor for residues in the target animals.

Tolerance means the maximum concentration of a marker residue, or other residue indicated for monitoring, that can legally remain in a specific edible tissue of a treated animal.

Total residue means the aggregate of all compounds that results from the use of an animal drug, including the drug, its metabolites, and any other substances formed in or on food because of such drug use.

µg/kg means microgram per kilogram.

Zero, in reference to tolerances in this part, means any residues detected in the edible tissue renders it unsafe.

§ 556.5General considerations.

(a) The tolerances listed in subpart B of this part pertain only to the species and production classes of the animal for which the drug use has been approved or conditionally approved. Approved and conditionally approved conditions of use in parts 516, 520, 522, 524, 526, 529, and 558 of this chapter, including the species and production classes of animals, are referenced in each tolerance section in subpart B of this part.

(b) All tolerances refer to the concentrations of a marker residue, or other residue indicated for monitoring, permitted in uncooked tissues.

(c) After a tolerance is listed, the finding that the concentration of the marker residue in the target tissue from a tested animal is at or below the tolerance indicates that all edible tissues (excluding milk and eggs unless otherwise indicated) from that tested animal are safe for human consumption. If a listed tolerance is not expressly linked to a target tissue, then the tolerance is specific only for the named edible tissue and inferences cannot be made about the safety of the other edible tissues from the tested animal.

(d) FDA requires that a drug sponsor submit a practicable method as part of their new animal drug application. FDA uses the practicable method to determine the quantity of the drug residues that can safely remain in edible tissues ( i.e., the tolerance), the withdrawal period, and any other use restrictions necessary to ensure that the proposed use of the drug will be safe.

§ 556.34Albendazole.

(a) Acceptable daily intake (ADI). The ADI for total residue of albendazole is 5 µg/kg of body weight per day.

(b) Tolerances. The tolerances for albendazole 2-aminosulfone (marker residue) are:

(1) Cattle. (i) Liver (target tissue): 0.2 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 §§ 520.38a and 520.38b of this chapter.

§ 556.36Altrenogest.

(a) Acceptable daily intake (ADI). The ADI for total residue of altrenogest is 0.04 µg/kg of body weight per day.

(b) Tolerances. The tolerances for altrenogest (marker residue) are:

(1) Swine. (i) Liver (target tissue): 4 ppb.

(ii) Muscle: 1 ppb.

(2) [Reserved]

(c) Related conditions of use. See § 520.48 of this chapter.

§ 556.38Amoxicillin.

(a) [Reserved]

(b) Tolerances. The tolerance for amoxicillin is:

(1) Cattle. Edible tissues: 0.01 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 520.88d, 520.88e, 522.88, and 526.88 of this chapter.

§ 556.40Ampicillin.

(a) [Reserved]

(b) Tolerances. The tolerances for ampicillin are:

(1) Cattle. Edible tissues: 0.01 ppm.

(2) Swine. Edible tissues: 0.01 ppm.

(c) Related conditions of use. See §§ 520.90c, 522.90a, and 522.90b of this chapter.

§ 556.50Amprolium.

(a) [Reserved]

(b) Tolerances. The tolerances for amprolium are:

(1) Cattle. (i) Liver, kidney, and muscle: 0.5 ppm.

(ii) Fat: 2.0 ppm.

(2) Chickens and turkeys. (i) Liver and kidney: 1 ppm.

(ii) Muscle: 0.5 ppm.

(iii) Eggs:

(A) Egg yolks: 8 ppm.

(B) Whole eggs: 4 ppm.

(3) Pheasants. (i) Liver: 1 ppm.

(ii) Muscle: 0.5 ppm.

(c) Related conditions of use. See §§ 520.100, 558.55, and 558.58 of this chapter.

§ 556.52Apramycin.

(a) Acceptable daily intake (ADI). The ADI for total residue of apramycin is 25 µg/kg of body weight per day.

(b) Tolerances. The tolerance for apramycin (marker residue) is:

(1) Swine. Kidney (target tissue): 0.1 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 520.110 and 558.59 of this chapter.

§ 556.60Avilamycin.

(a) Acceptable daily intake (ADI). The ADI for total residue of avilamycin is 1.1 mg/kg of body weight per day.

(b) Tolerances. The tolerances for avilamycin are:

(1) Chickens. Edible tissues (excluding eggs): Not required.

(2) Swine. Edible tissues: Not required.

(c) Related conditions of use. See § 558.68 of this chapter.

§ 556.68Azaperone.

(a) Acceptable daily intake (ADI). The ADI for total residue of azaperone is 0.63 µg/kg of body weight per day.

(b) Tolerances. The tolerance for azaperone is:

(1) Swine. Edible tissues: Not required.

(2) [Reserved]

(c) Related conditions of use. See § 522.150 of this chapter.

§ 556.70Bacitracin.

(a) Acceptable daily intake (ADI). The ADI for total residue of bacitracin is 0.05 mg/kg of body weight per day.

(b) Tolerances. The tolerances for bacitracin are:

(1) Cattle. Edible tissues: 0.5 ppm.

(2) Chickens, turkeys, pheasants, quail. Edible tissues: 0.5 ppm.

(3) Swine. Edible tissues: 0.5 ppm.

(c) Related conditions of use. See §§ 520.154a, 520.154c, 558.76, and 558.78 of this chapter.

§ 556.75Bambermycins.

(a) [Reserved]

(b) Tolerances. The tolerances for bambermycins are:

(1) Cattle. Edible tissues (excluding milk): Not required.

(2) Chickens and turkeys. Edible tissues (excluding eggs): Not required.

(3) Swine. Edible tissues: Not required.

(c) Related conditions of use. See § 558.95 of this chapter.

§ 556.100Carbadox.

(a) [Reserved]

(b) Tolerances. The tolerance for quinoxaline-2-carboxylic acid (marker residue) is:

(1) Swine. Liver (target tissue): 30 ppb.

(2) [Reserved]

(c) Related conditions of use. See § 558.115 of this chapter.

§ 556.110Carbomycin.

(a) [Reserved]

(b) Tolerances. The tolerance for carbomycin is:

(1) Chickens. Edible tissues (excluding eggs): Zero.

(2) [Reserved]

(c) Related conditions of use. See § 520.1664 of this chapter.

§ 556.113Ceftiofur.

(a) Acceptable daily intake and acute reference dose —(1) Acceptable daily intake (ADI). The ADI for total residue of ceftiofur is 30 µg/kg of body weight per day.

(2) Acute reference dose (ARfD). The ARfD for total residue of ceftiofur is 0.830 mg/kg of body weight.

(b) Tolerances. The tolerances for desfuroylceftiofur (marker residue) are:

(1) Cattle. (i) Kidney (target tissue): 0.4 ppm.

(ii) Liver: 2 ppm.

(iii) Muscle: 1 ppm.

(iv) Milk: 0.1 ppm.

(2) Chickens and turkeys. Edible tissues (excluding eggs): Not required.

(3) Goats. (i) Kidney (target tissue): 8 ppm.

(ii) Liver: 2 ppm.

(iii) Muscle: 1 ppm.

(iv) Milk: 0.1 ppm.

(4) Sheep. Edible tissues (excluding milk): Not required.

(5) Swine. (i) Kidney (target tissue): 0.25 ppm.

(ii) Liver: 3 ppm.

(iii) Muscle: 2 ppm.

(c) Related conditions of use. See §§ 522.313a, 522.313b, 522.313c, and 526.313 of this chapter.

§ 556.115Cephapirin.

(a) [Reserved]

(b) Tolerances. The tolerances for cephapirin are:

(1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.

(ii) Milk: 0.02 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 526.363 and 526.365 of this chapter.

§ 556.118Chloramine-T.

(a) Acceptable daily intake (ADI). The ADI for total residue of chloramine-T is 5 µg/kg of body weight per day.

(b) Tolerances. The tolerance for para -toluenesulfonamide (marker residue) is:

(1) Fish. Muscle/skin (target tissue): 0.9 ppm.

(2) [Reserved]

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

§ 556.120Chlorhexidine.

(a) [Reserved]

(b) Tolerances. The tolerance for chlorhexidine is:

(1) Cattle. Edible tissues (excluding milk): Zero.

(2) [Reserved]

(c) Related conditions of use. See § 529.400 of this chapter.

§ 556.150Chlortetracycline.

(a) Acceptable daily intake (ADI). The ADI for total residue of tetracyclines including chlortetracycline, oxytetracycline, and tetracycline is 25 µg/kg of body weight per day.

(b) Tolerances. The tolerances for the sum of tetracycline residues are:

(1) Cattle. (i) Liver: 6 ppm.

(ii) Kidney and fat: 12 ppm.

(iii) Muscle: 2 ppm.

(2) Chickens, turkeys, and ducks. (i) Liver: 6 ppm.

(ii) Kidney and fat: 12 ppm.

(iii) Muscle: 2 ppm.

(iv) Eggs: 0.4 ppm for chlortetracycline only.

(3) Sheep. (i) Liver: 6 ppm.

(ii) Kidney and fat: 12 ppm.

(iii) Muscle: 2 ppm.

(4) Swine. (i) Liver: 6 ppm.

(ii) Kidney and fat: 12 ppm.

(iii) Muscle: 2 ppm.

(c) Related conditions of use. See §§ 520.441, 520.443, 520.445, 558.128, and 558.140 of this chapter.

§ 556.160Clopidol.

(a) [Reserved]

(b) Tolerances. The tolerances for clopidol are:

(1) Chickens and turkeys. (i) Liver and kidney: 15 ppm.

(ii) Muscle: 5 ppm.

(2) [Reserved]

(c) Related conditions of use. See § 558.175 of this chapter.

§ 556.163Clorsulon.

(a) Acceptable daily intake (ADI). The ADI for total residue of clorsulon is 8 µg/kg of body weight per day.

(b) Tolerances. The tolerances for clorsulon (marker residue) are:

(1) Cattle. (i) Kidney (target tissue): 1.0 ppm.

(ii) Muscle: 0.1 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 520.462 and 522.1193 of this chapter.

§ 556.165Cloxacillin.

(a) [Reserved]

(b) Tolerances. The tolerance for cloxacillin is:

(1) Cattle. Edible tissues: 0.01 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 526.464 and 526.465 of this chapter.

§ 556.167Colistimethate.

(a) [Reserved]

(b) Tolerances. The tolerance for colistimethate is:

(1) Chickens. Edible tissues (excluding eggs): Not required.

(2) [Reserved]

(c) Related conditions of use. See § 522.468 of this chapter.

§ 556.168Coumaphos.

(a) [Reserved]

(b) Tolerances. The tolerances for coumaphos (measured as coumaphos and its oxygen analog, O,O-diethyl O-3- chloro-4-methyl-2-oxo-2 H-1- benzopyran-7-yl phosphate) are:

(1) Chickens. (i) Edible tissues (excluding eggs): 1 ppm.

(ii) Eggs: 0.1 ppm.

(2) [Reserved]

(c) Related conditions of use. See § 558.185 of this chapter.

§ 556.169Danofloxacin.

(a) Acceptable daily intake (ADI). The ADI for total residue of danofloxacin is 2.4 µg/kg of body weight per day.

(b) Tolerances. The tolerances for danofloxacin (marker residue) are:

(1) Cattle. (i) Liver (target tissue): 0.2 ppm.

(ii) Muscle: 0.2 ppm.

(2) [Reserved]

(c) Related conditions of use. See § 522.522 of this chapter.

§ 556.170Decoquinate.

(a) Acceptable daily intake (ADI). The ADI for total residue of decoquinate is 75 µg/kg of body weight per day.

(b) Tolerances. The tolerances for decoquinate are:

(1) Cattle. (i) Muscle: 1 ppm.

(ii) Other edible tissues (excluding milk): 2 ppm.

(2) Chickens. (i) Muscle: 1 ppm.

(ii) Other edible tissues (excluding eggs): 2 ppm.

(3) Goats. (i) Muscle: 1 ppm.

(ii) Other edible tissues (excluding milk): 2 ppm.

(c) Related conditions of use. See §§ 520.534 and 558.195 of this chapter.

§ 556.180Dichlorvos.

(a) [Reserved]

(b) Tolerances. The tolerance for dichlorvos is:

(1) Swine. Edible tissues: 0.1 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 520.596 and 558.198 of this chapter.

§ 556.185Diclazuril.

(a) Acceptable daily intake (ADI). The ADI for total residue of diclazuril is 25 µg/kg of body weight per day.

(b) Tolerances. The tolerances for diclazuril are:

(1) Chickens and turkeys. (i) Liver: 3 ppm.

(ii) Muscle: 0.5 ppm.

(iii) Skin/fat: 1 ppm.

(2) [Reserved]

(c) Related conditions of use. See § 558.205 of this chapter.

§ 556.200Dihydrostreptomycin.

(a) [Reserved]

(b) Tolerances. The tolerances for dihydrostreptomycin are:

(1) Cattle. (i) Kidney: 2.0 ppm.

(ii) Other edible tissues (excluding milk): 0.5 ppm.

(iii) Milk: 0.125 ppm.

(2) Swine. (i) Kidney: 2.0 ppm.

(ii) Other edible tissues: 0.5 ppm.

(c) Related conditions of use. See §§ 522.650, 526.1696b, and 526.1696c of this chapter.

§ 556.222Doramectin.

(a) Acceptable daily intake (ADI). The ADI for total residue of doramectin is 0.75 µg/kg of body weight per day.

(b) Tolerances. The tolerances for doramectin (marker residue) are:

(1) Cattle. (i) Liver (target tissue): 300 ppb.

(ii) Muscle: 30 ppb.

(2) Swine. Liver (target tissue): 160 ppb.

(c) Related conditions of use. See §§ 522.770, 522.772, and 524.770 of this chapter.

§ 556.224Efrotomycin.

(a) Acceptable daily intake (ADI). The ADI for total residue of efrotomycin is 10 µg/kg of body weight per day.

(b) Tolerances. The tolerance for efrotomycin is:

(1) Swine. Edible tissues: Not required.

(2) [Reserved]

(c) Related conditions of use. See § 558.235 of this chapter.

§ 556.226Enrofloxacin.

(a) Acceptable daily intake (ADI). The ADI for total residue of enrofloxacin is 3 µg/kg of body weight per day.

(b) Tolerances. The tolerances for enrofloxacin are:

(1) Cattle. Liver (target tissue): 0.1 ppm desethylene ciprofloxacin (marker residue).

(2) Swine. Liver (target tissue): 0.5 ppm enrofloxacin (marker residue).

(c) Related conditions of use. See §§ 516.812 and 522.812 of this chapter.

§ 556.227Eprinomectin.

(a) Acceptable daily intake (ADI). The ADI for total residue of eprinomectin is 10 µg/kg of body weight per day.

(b) Tolerances. The tolerances for eprinomectin B 1a (marker residue) are:

(1) Cattle. (i) Liver (target tissue): 1.5 ppm.

(ii) Muscle: 100 ppb.

(iii) Milk: 12 ppb.

(2) [Reserved]

(c) Related conditions of use. See §§ 522.814 and 524.814 of this chapter.

§ 556.230Erythromycin.

(a) [Reserved]

(b) Tolerances. The tolerances for erythromycin are:

(1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.

(ii) Milk: Zero.

(2) Chickens and turkeys. (i) Edible tissues (excluding eggs): 0.125 ppm.

(ii) Eggs: 0.025 ppm.

(c) Related conditions of use. See §§ 520.823, 522.820, 526.820, and 558.248 of this chapter.

§ 556.240Estradiol and related esters.

(a) [Reserved]

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

(1) Cattle. (i) Muscle: 0.2 ppb.

(ii) Liver: 0.6 ppb.

(iii) Kidney: 1.2 ppb.

(iv) Fat: 1.2 ppb.

(2) [Reserved]

(c) Related conditions of use. See §§ 522.840, 522.850, 522.1940, 522.2343, 522.2477, and 522.2478 of this chapter.

§ 556.260Ethopabate.

(a) [Reserved]

(b) Tolerances. The tolerances for ethopabate, measured as metaphenetidine, are:

(1) Chickens. (i) Liver: 1.5 ppm.

(ii) Kidney: 1.5 ppm.

(iii) Muscle: 0.5 ppm.

(2) [Reserved]

(c) Related conditions of use. See § 558.58 of this chapter.

§ 556.273Famphur.

(a) [Reserved]

(b) Tolerances. The tolerance for famphur including its oxygen analog is:

(1) Cattle. Edible tissues (excluding milk): 0.1 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 520.1242g, 524.900, and 558.254 of this chapter.

§ 556.275Fenbendazole.

(a) Acceptable daily intake (ADI). The ADI for total residue of fenbendazole is 40 µg/kg of body weight per day.

(b) Tolerances. The tolerances for fenbendazole are:

(1) Cattle. (i) Liver (target tissue): 0.8 ppm fenbendazole (marker residue).

(ii) Milk: 0.22 ppm fenbendazole sulfoxide (marker residue).

(2) Chickens. (i) Liver (target tissue): 5.2 ppm fenbendazole sulfone (marker residue).

(ii) Eggs: 1.8 ppm fenbendazole sulfone (marker residue).

(3) Goats. (i) Liver (target tissue): 0.8 ppm fenbendazole (marker residue).

(ii) [Reserved]

(4) Swine. (i) Liver (target tissue): 3.2 ppm fenbendazole (marker residue).

(ii) [Reserved]

(5) Turkeys. (i) Liver (target tissue): 6 ppm fenbendazole sulfone (marker residue).

(ii) [Reserved]

(6) Quail. (i) Liver (target tissue): 6 ppm fenbendazole sulfone (marker residue).

(ii) [Reserved]

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

§ 556.277Fenprostalene.

(a) Acceptable daily intake (ADI). The ADI for total residue of fenprostalene is 0.08 µg/kg of body weight per day.

(b) Tolerances. The tolerances for fenprostalene are:

(1) Cattle. Edible tissues (excluding milk): Not required.

(2) Swine. Edible tissues: Not required.

(c) Related conditions of use. See § 522.914 of this chapter.

§ 556.280Fenthion.

(a) [Reserved]

(b) Tolerances. The tolerance for fenthion is:

(1) Cattle. Edible tissues (excluding milk): 0.1 ppm.

(2) [Reserved]

(c) Related conditions of use. See § 524.920 of this chapter.

§ 556.283Florfenicol.

(a) Acceptable daily intake (ADI). The ADI for total residue of florfenicol is 10 µg/kg of body weight per day.

(b) Tolerances. The tolerances for florfenicol amine (marker residue) are:

(1) Cattle. (i) Liver (target tissue): 3.7 ppm.

(ii) Muscle: 0.3 ppm.

(2) Swine. (i) Liver (target tissue): 2.5 ppm.

(ii) Muscle: 0.2 ppm.

(3) Catfish. Muscle (target tissue): 1 ppm.

(4) Freshwater-reared warmwater finfish (other than catfish) and salmonids. Muscle/skin (target tissue): 1 ppm.

(c) Related conditions of use. See §§ 520.955, 522.955, 522.956, and 558.261 of this chapter.

§ 556.286Flunixin.

(a) Acceptable daily intake (ADI). The ADI for total residue of flunixin is 0.72 µg/kg of body weight per day.

(b) Tolerances. The tolerances for flunixin are:

(1) Cattle. (i) Liver (target tissue): 125 ppb flunixin free acid (marker residue).

(ii) Muscle: 25 ppb flunixin free acid.

(iii) Milk: 2 ppb 5-hydroxy flunixin (marker residue).

(2) Swine. (i) Liver (target tissue): 30 ppb flunixin free acid (marker residue).

(ii) Muscle: 25 ppb flunixin free acid.

(c) Related conditions of use. See §§ 522.956, 522.970, 522.1664, and 524.970 of this chapter.

§ 556.290Fluralaner.

(a) Acceptable daily intake (ADI). The ADI for total residue of fluralaner is 10 µg/kg of body weight per day.

(b) Tolerances. The tolerances for parent fluralaner (marker residue) are:

(1) Chickens. (i) Liver (target tissue): 320 ppb.

(ii) Muscle: 110 ppb.

(iii) Eggs: 2500 ppb.

(2) [Reserved]

(c) Related conditions of use. See § 520.999 of this chapter.

§ 556.292Gamithromycin.

(a) Acceptable daily intake (ADI). The ADI for total residue of gamithromycin is 10 µg/kg of body weight per day.

(b) Tolerances. The tolerances for gamithromycin (marker residue) are:

(1) Cattle. (i) Liver (target tissue): 500 ppb.

(ii) Muscle: 150 ppb.

(2) [Reserved]

(c) Related conditions of use. See § 522.1014 of this chapter.

§ 556.300Gentamicin.

(a) Acceptable daily intake (ADI). The ADI for total residue of gentamicin is 60 µg/kg of body weight per day.

(b) Tolerances. The tolerances for gentamicin are:

(1) Chickens and turkeys. Edible tissues (excluding eggs): 0.1 ppm.

(2) Swine. (i) Liver: 0.3 ppm.

(ii) Kidney (target tissue): 0.4 ppm gentamicin (marker residue).

(iii) Fat: 0.4 ppm.

(iv) Muscle: 0.1 ppm.

(c) Related conditions of use. See §§ 520.1044a, 520.1044b, 520.1044c, 522.1044, 524.1044e, and 529.1044b of this chapter.

§ 556.304Gonadotropin.

(a) Acceptable daily intake (ADI). The ADI for residues of total gonadotropins (human chorionic gonadotropin and pregnant mare serum gonadotropin) is 42.25 International Units per kilogram of body weight per day.

(b) Tolerances. The tolerances for gonadotropin are:

(1) Cattle. Edible tissues (excluding milk): Not required.

(2) Fish. Edible tissues: Not required.

(3) Swine. Edible tissues: Not required.

(c) Related conditions of use. See §§ 522.1079 and 522.1081 of this chapter.

§ 556.308Halofuginone.

(a) Acceptable daily intake (ADI). The ADI for total residue of halofuginone hydrobromide is 0.7 µg/kg of body weight per day.

(b) Tolerances. The tolerances for halofuginone (marker residue) are:

(1) Chickens. Liver (target tissue): 0.16 ppm.

(2) Turkeys. Liver (target tissue): 0.13 ppm.

(c) Related conditions of use. See § 558.265 of this chapter.

§ 556.310Haloxon.

(a) [Reserved]

(b) Tolerances. The tolerance for haloxon is:

(1) Cattle. Edible tissues (excluding milk): 0.1 ppm.

(2) [Reserved]

(c) Related conditions of use. See §§ 520.1120a and 520.1120b of this chapter.

§ 556.316Hetacillin.

(a) [Reserved]

(b) Tolerances. The tolerances for ampicillin (marker residue for hetacillin) are:

(1) Cattle. Edible tissues: 0.01 ppm.

(2) [Reserved]

(c) Related conditions of use. See § 526.1130 of this chapter.

106 sections

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TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD (U.S.C.). Retrieved via LawPlayer, https://lawplayer.com/us/act/cfr-title-21-part-556

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