558.58—Amprolium and ethopabate.

(a) Specifications. Type A medicated articles containing:

(1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate;

(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate.

(b) Approvals. See No. 016592 in § 510.600(c) of this chapter.

(d) Related tolerances. See §§ 556.50 and 556.260 of this chapter.

(e) Conditions of use. (1) It is used for chickens as follows:

Amprolium and ethopabate in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(i) Amprolium 113.5 (0.0125 pct) and ethopabate 3.6 (0.0004 pct)		Broiler chickens as an aid in the prevention of coccidiosis	Not for laying hens; as sole source of amprolium	016592
	Bambermycins, 1 to 3; plus roxarsone, 22.8 to 34.1	Broiler chickens: As an aid in the prevention of coccidiosis; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.	Feed continuously as the sole ration; as sole source of amprolium and organic arsenic; withdraw 5 d before slaughter; roxarsone provided by No. 046573, bambermycins by No. 016592 in § 510.600(c) of this chapter.	016592
Code of Federal Regulations 401
(ii) Amprolium 113.5 (0.0125%) and ethopabate 3.6 (0.0004%)	Bambermycins 2 to 3 plus roxarsone 22.8 to 34.1 (0.0025% to 0.00375%)	Broiler chickens; as an aid in the prevention of coccidiosis; for increased rate of weight gain, improved feed efficiency, and pigmentation	Feed continuously as the sole ration; as sole source of amprolium and organic arsenic; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter, roxarsone by No. 046573, bambermycins by No. 016592; withdraw 5 d before slaughter	016592
	Lincomycin 2 to 4	Broiler chickens; for increase in rate of weight gain; improved feed efficiency; as an aid in the prevention of coccidiosis	Not for laying chickens; as lincomycin hydrochloride monohydrate; as sole source of amprolium
	Lincomycin 2 to 4 plus roxarsone 45.4 (0.005%)	Broiler chickens; for increase in rate of weight gain; improved feed efficiency and pigmentation; as an aid in the prevention of coccidiosis	Not for laying chickens; as lincomycin hydrochloride monohydrate; withdraw 5 d before slaughter; as sole source of amprolium and organic arsenic
	Roxarsone 45.4 (0.005 pct)	Broiler chickens; to aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain in broiler chickens raised in floor pens	Do not feed to laying chickens; withdraw 5 d before slaughter; as sole source of amprolium; do not use as a treatment for outbreaks of coccidiosis; feed as sole ration from time chickens are placed on litter until the past the time when coccidiosis is ordinarily a hazard; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combinations as provided by No. 016592
(iii) Amprolium 113.5 (0.0125%) and ethopabate 36.3 (0.004%)		Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur	Not for chickens over 16 weeks of age
	Arsanilic acid 90 (0.01 pct) plus erythromycin 4.6 to 18.5	Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improve pigmentation	Not for laying hens; withdraw 5 d before slaughter; as sole source of organic arsenic; as erythromycin thiocyanate	061133
	Bacitracin 4 to 50	1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; to aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain in broiler chickens raised in floor pens	Not for chickens over 16 weeks of age; do not feed to laying chickens; as sole source of amprolium; not for use as a treatment for outbreaks of coccidiosis; as bacitracin methylene disalicylate as provided by No. 046573 or bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter; feed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard; combination as provided by No. 016592 in § 510.600(c) of this chapter
Code of Federal Regulations 402
		2. Broiler chickens; as an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; improved feed efficiency	Not for chickens over 16 weeks of age; do not feed to laying chickens; as sole source of amprolium; not for use as a treatment for coccidiosis; bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter; feed as the sole ration from the time chickens are placed on litter until market weight; combination as provided by No. 046573.	046573
	Bacitracin 5 to 35 plus roxarsone 34 (0.00375%)	Broiler chickens; for increased rate of weight gain and as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur in broiler chickens raised in floor pens	Do not feed to laying chickens; withdraw 5 d before slaughter; as sole source of amprolium and organic arsenic; do not use as a treatment for outbreaks of coccidiosis; feed as the sole ration from time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter; bacitracin methylene disalicylate as provided by No. 046573 or bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combination as provided by No. 016592 in § 510.600(c) of this chapter
	Bacitracin 20 to 35 plus roxarsone 34 (0.00375%)	Broiler chickens; for increased rate of weight gain, improved feed efficiency, and as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur in broiler chickens raised in floor pens	Do not feed to laying chickens; withdraw 5 d before slaughter; as sole source of amprolium and organic arsenic; do not use as a treatment for outbreaks of coccidiosis; feed as the sole ration from time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter; bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combination as provided by No. 016592 in § 510.600(c) of this chapter
Code of Federal Regulations 403
	Bacitracin 10 to 50 plus roxarsone 15.4 to 45.4 (0.0017% to 0.005%)	Broiler chickens; as an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; improved feed efficiency	Do not feed to laying chickens; withdraw 5 d before slaughter; as sole source of amprolium and organic arsenic; do not use as a treatment for outbreaks of coccidiosis; feed as the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter; bacitracin zinc as provided by No. 046573 roxarsone as provided by No. 046573 combination as provided by No. 046573	046573
	Bacitracin 10 plus roxarsone 30 to 45.4 (0.0033% to 0.005%)	Broiler chickens; as an aid in prevention of coccidiosis where severe exposure to coccidiosis from E. acervulina, E. maxima, and E. brunetti is likely to occur; improved feed efficiency and improved pigmentation	......do	063238
	Bambermycins 1 to 3	Broiler chickens; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain, and improved feed efficiency	Feed continuously as the sole ration; as sole source of amprolium; amprolium, ethopabate as provided by No. 016592 in § 510.600(c) of this chapter, bambermycins as provided by No. 016592 in § 510.600(c) of this chapter	016592
	Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1 (0.0025% to 0.00375%)	Broiler chickens; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain; improved feed efficiency, and improved pigmentation	Feed continuously as the sole ration; as sole source of amprolium and organic arsenic; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter, roxarsone by No. 046573 bambermycins by No. 016592. Withdraw 5 days before slaughter	016592
	Erythromycin 4.6 to 18.5	Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency	Not for laying hens; withdraw 24 hours before slaughter; erythromycin thiocyanate
	Virginiamycin, 15	Broiler chickens, as an aid in the prevention of coccidiosis where severe exposure to Eimeria acervulina, E. brunetti, and E. maxima is likely to occur, for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration, do not feed to laying hens, not for chickens over 16 weeks of age, as sole source of amprolium, amprolium and ethopabate as provided by 016592 in § 510.600(c) , virginiamycin as provided by 066104	000069
Code of Federal Regulations 404
	Virginiamycin, 5 to 15	Broiler chickens, as an aid in the prevention of coccidiosis where severe exposure to Eimeria acervulina, E. brunetti, and E. maxima is likely to occur, for increased rate of weight gain	......do
(iv) Amprolium 113.5 to 227 (0.0125% to 0.025%) and ethopabate 3.6 (0.0004%)		For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis	Not for laying hens
	Arsanilic acid 90 (0.01%)	Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation	As sole source of organic arsenic; withdraw 5 d before slaughter; not for laying hens
	Arsanilic acid 90 (0.01%) plus erythromycin 92.5	1. For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stress; growth promotion and feed efficiency; improving pigmentation	Feed for 2 d before stress and 3 to 6 d after stress; withdraw 5 d before slaughter; as sole source of organic arsenic; not for laying hens
	2. For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of infectious coryza; growth promotion and feed efficiency; improving pigmentation	Feed for 7 to 14 d; withdraw 5 d before slaughter; as sole source of organic arsenic; not for laying hens
	Arsanilic acid 90 (0.01%) plus erythromycin 185	For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease; growth promotion and feed efficiency; improving pigmentation	Feed for 5 to 8 d; do not use in birds producing eggs for food purposes; withdraw 5 d before slaughter; as sole source of organic arsenic
	Bacitracin 4 to 50	For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency	As bacitracin methylene disalicylate; not for laying hens
	Bacitracin 100 to 200	1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection) and blue comb (nonspecific infectious enteritis)	......do
	2. For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection), blue comb (nonspecific infectious enteritis)	As zinc bacitracin, not for laying hens
Code of Federal Regulations 405
	Bacitracin 4 to 50 plus roxarsone 22.7 to 45.4 (0.0025% to 0.005%)	Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation	As bacitracin methylene disalicylate; not for laying hens; as sole source of organic arsenic; withdraw 5 d before slaughter
	Chlortetracycline 100 to 200	For chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline	Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
	Chlortetracycline 200 to 400	For chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline	In low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 d; do not feed to chickens producing eggs for human consumption
	Erythromycin 92.5	1. For broiler chickens and for replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stress	Feed for 2 d before stress and 3 to 6 d after stress; withdraw 24 h before slaughter; not for laying hens
	2. For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of infectious coryza	Feed for 7 to 14 d; withdraw 24 h before slaughter; not for laying hens
	Erythromycin 185	For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease	Feed for 5 to 8 d; do not use in birds producing eggs for food purposes; withdraw 48 h before slaughter
	Penicillin 2.4 to 50	For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation	Not for laying hens; as procaine penicillin
	Roxarsone 22.7 to 45.4 (0.0025% to 0.005%)	Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation	As sole source of organic arsenic; withdraw 5 d before slaughter; not for laying hens

(2) [Reserved]

Code of Federal Regulations

[41 FR 10990, Mar. 15, 1976]

Code of Federal Regulations

Code of Federal Regulations 406

Editorial Note: For Federal Register citations affecting § 558.58 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.