§ 558.500. Ractopamine.

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(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)Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride.

(2)Nos. 051311 and 066104: 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 A medicated articles and Type B and Type C feeds shall bear the following: “Not for use in 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 hydrochloride concentrations in the diet are greater than 4.5 g/ton (5 ppm).”

(ii)“Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride.”

(iii)“Additional Recommendations: To help mitigate the signs identified in the Animal Safety Warnings section, see the Pork Quality Assurance (PQA Plus) and Transport Quality Assurance

(TQA)recommendations for best practices in swine care during handling, transport, and 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.

(6)Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for cattle feeds shall bear the following:

(i)“Behavioral signs such as agitation and decreased feed consumption have been reported in cattle fed ractopamine hydrochloride.”

(ii)“Additional Recommendations: See the Beef Quality Assurance

(BQA)recommendations for best practices in cattle care and handling during ractopamine hydrochloride feeding, transport, and marketing to help mitigate the behavioral signs stated in the Animal Safety Warnings section above.”

(e)Conditions of use—(1) Swine— Ractopamine hydrochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor

(i)4.5 to 9.0For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine, weighing at least 150 lb, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughterNot for use in swine intended for breeding. Feed as sole ration016592

(ii)[Reserved]

(2)Cattle. Ractopamine hydrochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor

(i)8.2 to 24.6For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feedFeed as the sole ration to provide 70 to 430 mg of ractopamine hydrochloride per head per day during the last 28 to 42 days on feed. Not for use in cattle intended for breeding016592 051311 066104 058198

(ii)8.2 to 24.6 to provide 70 to 430 mg/head/dayMonensin 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/dayCattle 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 feedFeed 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, 066104, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592 066104 058198

(iii)9.8 to 24.6For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feedFeed as the sole ration to provide 90 to 430 mg ractopamine hydrochloride per head per day during the last 28 to 42 days on feed. Not for use in cattle intended for breeding016592 051311 066104 058198

(iv)9.8 to 24.6 to provide 90 to 430 mg/head/dayMonensin 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/dayCattle 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 feedFeed 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 chapter016592 066104 058198

(v)9.8 to 24.6 to provide 90 to 430 mg/head/dayMonensin 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/dayHeifers 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 feedFeed 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 chapter016592 066104 058198

(vi)100 to 800For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feedFeed a minimum of 1 lb per head per day of Type C top-dress medicated feed to provide 70 to 400 mg ractopamine hydrochloride per head per day during the last 28 to 42 days on feed. Not for use in cattle intended for breeding016592 051311 066104 058198

(vii)Not to exceed 800; to provide 70 to 400 mg/head/dayMonensin 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/dayCattle 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 feedTop 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 chapter016592 066104 058198

(3)Turkeys— Ractopamine hydrochloride 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 90Finishing 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 90Finishing 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; 91 FR 20346, Apr. 16, 2026] Editorial Note:At 91 FR 20346, Apr. 16, 2026, § 558.500 was amended; however, a portion of the amendment could not be incorporated due to inaccurate amendatory instruction.

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§ 558.500

Ractopamine.

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