558.550—Salinomycin.

(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin activity per pound (as salinomycin sodium biomass).

(b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section:

(1) No. 046573 for use as in paragraph (d) of this section.

(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii) through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), (d)(3)(i), and (d)(4) of this section.

(3) No. 048164 for use as in paragraphs (d)(1)(xv) and (d)(1)(xvi) of this section.

(d) Conditions of use. (1) Broilers: It is used as follows:

(i) (a) Amount per ton. Salinomycin 40 to 60 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(c) Limitations. Feed continuously as sole ration. Do not feed to layers. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses.

(ii) (a) Amount per ton. Salinomycin 40 to 60 grams and roxarsone 45.4 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 011526 or 046573 in § 510.600(c) of this chapter.

(iii) (a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 30 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati for incresed rate of weight gain and improved feed efficiency.

(c) Limitation. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentially fed to adult turkeys or horses. Bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter.

(iv) (a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 45.4 grams and bacitracin methylene disalicylate 4 to 50 grams.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone and bacitracin as provided by No. 046573 in § 510.600(c) of this chapter.

(v) (a) Amount per ton. Salinomycin 40 to 60 grams per ton with roxarsone 22.7 to 45.4 grams per ton.

(b) Indications for use. For the prevention of coccidiosis caused by Eimera tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidently fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(vi) (a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin MD as provided by No. 046573 in § 510.600(c) of this chapter.

(vii) (a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin zinc 10 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter.

(viii) (a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 45.4 grams and bacitracin zinc 4 to 50 grams.

(ix) (a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 34.1 grams and bacitracin zinc 10 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 046573 and bacitracin as provided by No. 046573 in § 510.600(c) of this chapter.

(x) (a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 grams.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers or to chickens over 16 weeks of age. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter.

(xi) (a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 to 15 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.

(xii) (a) Amount per ton. Salinomycin 40 to 60 grams, virginiamycin 5 grams, and roxarsone 45.4 grams.

(b) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone, and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Withdraw 5 days prior to slaughter. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter. Roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(xiii) (a) Amount per ton. Salinomycin 40 to 60 grams and lincomycin 2 to 4 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. Do not allow horses, adult turkeys, guinea pigs, rabbits, hamsters, or ruminants access to this feed. Ingestion by these species may result in severe gastrointestinal effects or may be fatal. Lincomycin hydrochloride monohydrate as provided by No. 000009 in § 510.600(c) of this chapter.

(xiv) (a) Amount per ton. Salinomycin 40 to 60 grams, roxarsone 45.4 grams, and lincomycin 2 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than to salinomycin alone, and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Drug overdose or lack of water may result in leg weakness. Do not feed to layers. Do not allow horses, adult turkeys, guinea pigs, rabbits, hamsters, or ruminants access to this feed. Ingestion by these species may result in severe gastrointestinal effects or may be fatal. Withdraw 5 days before slaughter. Lincomycin hydrochloride monohydrate as provided by No. 000009 in § 510.600(c) of this chapter. Roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(xv) (a) Amount per ton. Salinomycin 40 to 60 grams, chlortetracycline 500 grams, and roxarsone 45.4 grams.

(c) Limitations. Do not feed to layers. In feeds containing 0.8 percent dietary calcium, not to be fed for more than 5 days. Not approved for use with pellet binders. Withdraw 5 days before slaughter. May be fatal if accidentally fed to adult turkeys or to horses. Chlortetracycline as provided by Nos. 046573 and 048164; roxarsone as provided by No. 046573; and salinomycin as provided by Nos. 046573 and 016592 in § 510.600(c) of this chapter.

(xvi) (a) Amount per ton. Salinomycin 40 to 60 grams and chlortetracycline 500 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E., necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.

(c) Limitations. Do not feed to layers. In feeds containing 0.8 percent dietary calcium. Not to be fed for more than 5 days. Not approved for use with pellet binders. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 046573 and 048164; salinomycin as provided by Nos. 046573 and 016592 in § 510.600(c) of this chapter.

(xvii) (A) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 34.1 or 45.4 grams and bacitracin methylene disalicylate 4 to 50 grams.

(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than to salinomycin alone; for increased rate of weight gain. Use of 34.1 or 45.4 grams per ton roxarsone is indicated to meet the E. tenella challenge which varies with environmental and management conditions.

(C) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to laying chickens. May be fatal if accidentally fed to adult turkeys or horses. Poultry should have access to drinking water at all times. Overdosage or lack of water may result in leg weakness or paralysis. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573 in § 510.600(c) of this chapter. Roxarsone and bacitracin as provided by No. 046573 in § 510.600(c) of this chapter.

(xviii) (A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.

(B) Indications for use. For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(C) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by Nos. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(xix) (A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 grams.

(B) Indications for use. For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(C) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(xx) (A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 50 grams.

(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(C) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) in this chapter.

(xxi) (A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 100 to 200 grams.

(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(xxii) Amount per ton. Salinomycin, 40 to 60 grams; plus tylosin, 4 to 50 grams.

(A) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by 046573; tylosin phosphate as provided by 000986 in § 510.600(c) of this chapter.

(xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 3 grams.

(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens; not approved for use with pellet binders; may be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by Nos. 046573 and 016592; bambermycins by No. 016592 in § 510.600(c) of this chapter.

(xxiv) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 2 grams; plus roxarsone, 45.4 grams.

(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens; as sole source or organic arsenic; withdraw 5 days before slaughter; not approved for use with pellet binders; may be fatal if accidentally fed to adult turkeys or horses; Salinomycin as provided by Nos. 046573and 016592; bambermycins by No. 016592; roxarsone by No. 046573 in § 510.600(c) of this chapter.

(2) Quail— (i) (a) Amount per ton. Salinomycin 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by E. dispersa and E. lettyae.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses.

(ii) [Reserved]

(3) Roaster and replacement (breeder and layer) chickens: It is used as follows:

(i) (A) Amount per ton. Salinomycin 40 to 60 grams.

(B) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(C) Limitations. Feed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to horses or adult turkeys.

(ii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 4 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.

(iii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(iv) (A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.

(C) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c).

(v) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 100 to 200 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(B) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.

(vi) (A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 grams.

(C) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Discontinue use prior to sexual maturity. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c).

(vii) Amount per ton. Salinomycin, 40 to 60 grams; and roxarsone, 22.7 to 45.4 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella ,E. necatrix ,E. acervulina ,E. brunetti ,E. mivati, andE. maxima, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573 and roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(4) Chickens: It is used in chicken feed as follows:

(i) Amount per ton. Salinomycin, 40 to 60 grams; plus oxytetracycline, 500 grams.

(a) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for reduction of mortality due to air sacculitis (air-sac-infection) caused by Escherichia coli susceptible to oxytetracycline.

(b) Limitations. Feed continuously for 5 days; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter. Salinomycin as provided by Nos. 046573 and 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.

(ii) [Reserved]

Code of Federal Regulations

[48 FR 30616, July 5, 1983]

Code of Federal Regulations

Editorial Note: For Federal Register citations affecting § 558.550 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.