§ 558.500 - Ractopamine.

§ 558.500 Ractopamine.

(a) Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

(1) No Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride.

(2) Nos. 016592, 051311 , and 054771: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride.

(c) Related tolerances. See § 556.570 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
(i) 4.5 to 9.0		For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine, weighing not less than 150 lbslb, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs lb of gain prior to slaughter	Feed continuously as sole ration	016592 054771 058198 , 054771
(ii) [Reserved]

(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. Not for animals intended for breeding	016592 051311 054771 058198
(ii) 8.2 to 24.6 to provide 70 to 430 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: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii 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. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter	016592 054771 058198
(iii) 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	016592 051311 054771 058198
(iv) 9.8 to 24.6 to provide 90 to 430 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: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii 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. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter	016592 054771 058198
(v) 9.8 to 24.6 to provide 90 to 430 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 melengestrol acetate to provide 0.25 to 0.5 mg/head/day	Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) 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. See special labeling considerations in §§ 558.342(d) and 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016592, 054771 or 058198 in § 510.600(c) of this chapter	016592 054771 058198
(vi) Not to exceed 800; to provide 70 to 400 mg/head/day		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	Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continuously during the last 28 to 42 days on feed. Not for animals intended for breeding	016592 051311 054771 058198
(vii) 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: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed	Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continuously during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter	016592 054771 058198

(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.	058198
(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.	058198
(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).	058198
(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).	058198

(4) Ractopamine may also be used in combination with tylosin in as in § 558.625.

[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; 77 FR 31724, May 30, 2012; 78 FR 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014; 79 FR 37621, July 2, 2014; 79 FR 44278, July 31, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61298, Oct. 13, 2015; 81 FR 48703, July 26, 2016; 81 FR 95013, Dec. 27, 2016; 85 FR 18122, Apr. 1, 2020; 85 FR 45311, July 28, 2020; 86 FR 58013, Oct. 20, 2021; 87 FR 17947, Mar. 29, 2022; 89 FR 42361, May 15, 2024]