558.500—Ractopamine.

(a) Specifications. Type A medicated articles containing 9 or 45 grams of ractopamine hydrochloride per pound.

(b) Approvals. See No. 000986 in § 510.600(c) of this chapter.

(d) Special considerations. (1) Labeling of Type B and Type C feeds shall bear the following: “Not for animals intended for breeding.”

(2) Labeling of Type B and Type C swine feeds shall bear the following:

(i) “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton.”

(ii) “Ractopamine may increase the number of injured and/or fatigued pigs during marketing.”

(3) Labeling of Type B and Type C tom turkey feeds shall bear the following: “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.6 g/ton.”

(4) Tylosin in combinations as tylosin phosphate.

(5) Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(e) Conditions of use— (1) Swine—

Ractopamine in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
(ii) 4.5 to 9	Tylosin40 or 100	Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of swine dysentery associated with Brachyspira hyodysenteriae and porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.	Feed 100 grams per tons (g/ton) continuously as sole ration for at least 3 weeks followed by 40 g/ton until market weight.	000986
(iii) 4.5 to 9	Tylosin100	Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.	Feed continuously as sole ration for 21 days.	000986
(iv) 4.5 to 9	Tylosin40 to 100	Finishing swine: As in paragraph (e)(1)(i) of this section; for treatment and control of swine dysentery associated with B. hyodysenteriae and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.	Feed continuously as sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water as in § 520.2640(d)(3) of this chapter.	000986

(2) Cattle—

Ractopamine in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
(i) 8.2 to 24.6		Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed	Feed continuously as sole ration during the last 28 to 42 days on feed.	000986
(ii) 8.2 to 24.6	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day	Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii.	As in paragraph (e)(2)(i) of this section; see paragraph §§ 558.355(d) of this chapter.	000986
(iii) [Reserved]
(iv) 8.2 to 24.6	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10	Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.	As in paragraph (e)(2)(i) of this section; see §§ 558.355(d) and 558.625(c) of this chapter.	000986
(v) [Reserved]
(vi) 9.8 to 24.6		Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed	Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding	000986
(vii) 9.8 to 24.6	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day	Cattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii.	As in paragraph (e)(2)(vi) of this section; see paragraph §§ 558.355(d) of this chapter.	000986
(viii) 9.8 to 24.6	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day	Heifers fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat).	As in paragraph (e)(2)(vi) of this section; see §§ 558.342(d) and 558.355(d) of this chapter. Melengestrol acetate as provided by No. 000009 or 021641 in § 510.600(c) of this chapter.	000986021641
Code of Federal Regulations 491
(ix) 9.8 to 24.6	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10	Cattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.	As in paragraph (e)(2)(vi) of this section; see §§ 558.355(d) and 558.625(c) of this chapter.	000986
(x) 9.8 to 24.6	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day	Heifers fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat).	As in paragraph (e)(2)(vi) of this section; see paragraphs §§ 558.342(d), 558.355(d) and 558.625(c) of this chapter. Melengestrol acetate as provided by Nos. 000009 and 021641 in § 510.600(c) of this chapter.	000986, 021641
(xi) Not to exceed 800; to provide 70 to 400 mg/head/day.		Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section.	Top dress in a minimum of 1.0 lb of medicated feed.	000986
(xii) Not to exceed 800; to provide 70 to 400 mg/head/day	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day.	Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.	Top dress ractopamine in a minimum of 1.0 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See § 558.355(d) .	000986
(xiii) Not to exceed 800; to provide 70 to 400 mg/head/day	Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10.	Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.	Top dress ractopamine in a minimum of 1.0 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See §§ 558.355(d) and 558.625(c) .	000986

(3) Turkeys—

Ractopamine in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
(i) 4.6 to 11.8 (5 to 13 ppm)		Finishing hen turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 7 to 14 days prior to slaughter.	Feed continuously as sole ration during the last 7 to 14 days prior to slaughter.	000986
(ii) 4.6 to 11.8 (5 to 13 ppm)		Finishing tom turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 14 days prior to slaughter.	Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.	000986
(iii) 4.6 to 11.8 (5 to 13 ppm)	Monensin 54 to 90	Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.	Feed continuously as sole ration during the last 7 to 14 days prior to slaughter. See § 558.355(d) .	000986
(iv) 4.6 to 11.8 (5 to 13 ppm)	Monensin 54 to 90	Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.	Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality. See § 558.355(d) .	000986

Code of Federal Regulations

[67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR 10358, Mar. 8, 2007; 72 FR 41619, July 31, 2007; 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, 2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Dec. 13, 2007; 73 FR 72715, Dec. 1, 2008; 73 FR 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 2009; 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, Apr. 22, 2010; 75 FR 54018, Sept. 3, 2010]

CFR

558.500—Ractopamine.

Code of Federal Regulations