PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B--Specific New Animal Drugs for Use in Animal Feeds

Sec. 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. (c)Related tolerances . See 556.570 of this chapter. (d)Special considerations . (1) Labeling of Type B and Type C swine feeds shall bear the following: (i) Ractopamine may increase the number of injured and/or fatigued pigs during marketing. (ii) "Not for use in breeding swine." (iii) No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton. (2) Tylosin in combinations as tylosin phosphate. (3) 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 (i) 4.5 to 9 For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. Feed continuously as sole ration. 000986 (ii) 4.5 to 9 Tylosin 40 Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of swine dysentery associated withBrachyspira hyodysenteriaeand porcine proliferative enteropathies (ileitis) associated withLawsonia intracellularis. Feed continuously as sole ration until market weight following the use of tylosin at 100 grams per ton (g/ton) for at least 3 weeks. 000986 (iii) 4.5 to 9 Tylosin 100 1. Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of porcine proliferative enteropathies (ileitis) associated withLawsonia intracellularis.2. Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of swine dysentery associated withBrachyspira hyodysenteriae. Feed continuously as sole ration for 21 days.Feed continuously as sole ration for at least 3 weeks followed by tylosin at 40 g/ton until market weight. 000986 (2)Cattle -- Ractopame 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. Not for animals intended for breeding 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 toEimeria bovisandE 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 toEimeria bovisandE. zuernii; and for reduction of incidence of liver abscesses caused byFusobacterium necrophorumandArcanobacterium (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 toEimeria bovisandE 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 toEimeria bovisandE. 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 in 510.600(c) of this chapter. 000986 (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 toEimeria bovisandE. zuernii; and for reduction of incidence of liver abscesses caused byFusobacterium necrophorumandArcanobacterium (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 toEimeria bovisandE. zuernii; for reduction of incidence of liver abscesses caused byFusobacterium necrophorumandArcanobacterium (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 No. 000009 in 510.600(c) of this chapter. 000986 (xi) 9.8 to 24.6 Monensin 10 to 30, 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 toEimeria bovisandE. zuernii; for reduction of incidence of liver abscesses caused byFusobacterium necrophorumandActinomyces (Corynebacterium) 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 No. 021641 in 510.600(c) of this chapter. 021641 (xii) 9.8 to 24.6 Monensin 10 to 30, 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 toEimeria bovisandE. 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. 021641 in 510.600(c) of this chapter. 021641 [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]