#### § 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](/on/2024-09-17/title-21/section-510.600#p-510.600(c)).

(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 054771: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride.

(c) *Related tolerances.* See [§ 556.570 of this chapter](/on/2024-09-17/title-21/section-556.570).

(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 lb, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter | Feed continuously as sole ration | 016592 054771 058198 |
| (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](/on/2024-09-17/title-21/section-558.355#p-558.355(d)). Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in [§ 510.600(c) of this chapter](/on/2024-09-17/title-21/section-510.600#p-510.600(c)) | 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](/on/2024-09-17/title-21/section-558.355#p-558.355(d)). Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in [§ 510.600(c) of this chapter](/on/2024-09-17/title-21/section-510.600#p-510.600(c)) | 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)](/on/2024-09-17/title-21/section-558.342#p-558.342(d)) and [558.355(d) of this chapter](/on/2024-09-17/title-21/section-558.355#p-558.355(d)). 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](/on/2024-09-17/title-21/section-510.600#p-510.600(c)) | 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](/on/2024-09-17/title-21/section-558.355#p-558.355(d)). Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in [§ 510.600(c) of this chapter](/on/2024-09-17/title-21/section-510.600#p-510.600(c)) | 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)](/on/2024-09-17/title-21/section-558.500#p-558.500(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)](/on/2024-09-17/title-21/section-558.355#p-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)](/on/2024-09-17/title-21/section-558.500#p-558.500(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)](/on/2024-09-17/title-21/section-558.355#p-558.355(d)). | 058198 |

(4) Ractopamine may also be used in combination with tylosin in as in [§ 558.625](/on/2024-09-17/title-21/section-558.625).

[[67 FR 71820](https://www.federalregister.gov/citation/67-FR-71820), Dec. 3, 2002, as amended at [68 FR 54659](https://www.federalregister.gov/citation/68-FR-54659), Sept. 18, 2003; [69 FR 12068](https://www.federalregister.gov/citation/69-FR-12068), Mar. 15, 2004; [69 FR 51174](https://www.federalregister.gov/citation/69-FR-51174), Aug. 18, 2004; [71 FR 31074](https://www.federalregister.gov/citation/71-FR-31074), June 1, 2006; [71 FR 67301](https://www.federalregister.gov/citation/71-FR-67301), Nov. 21, 2006; [72 FR 10358](https://www.federalregister.gov/citation/72-FR-10358), Mar. 8, 2007; [72 FR 41619](https://www.federalregister.gov/citation/72-FR-41619), July 31, 2007; [72 FR 56897](https://www.federalregister.gov/citation/72-FR-56897), Oct. 5, 2007; [72 FR 62571](https://www.federalregister.gov/citation/72-FR-62571), Nov. 6, 2007; [72 FR 65667](https://www.federalregister.gov/citation/72-FR-65667), Nov. 23, 2007; [72 FR 70777](https://www.federalregister.gov/citation/72-FR-70777), Dec. 13, 2007; [73 FR 72715](https://www.federalregister.gov/citation/73-FR-72715), Dec. 1, 2008; [73 FR 75323](https://www.federalregister.gov/citation/73-FR-75323), Dec. 11, 2008; [74 FR 66914](https://www.federalregister.gov/citation/74-FR-66914), Dec. 17, 2009; [75 FR 1276](https://www.federalregister.gov/citation/75-FR-1276), Jan. 11, 2010; [75 FR 5888](https://www.federalregister.gov/citation/75-FR-5888), Feb. 5, 2010; [75 FR 20917](https://www.federalregister.gov/citation/75-FR-20917), Apr. 22, 2010; [75 FR 54018](https://www.federalregister.gov/citation/75-FR-54018), Sept. 3, 2010; [77 FR 31724](https://www.federalregister.gov/citation/77-FR-31724), May 30, 2012; [78 FR 63872](https://www.federalregister.gov/citation/78-FR-63872), Oct. 25, 2013; [79 FR 13546](https://www.federalregister.gov/citation/79-FR-13546), Mar. 11, 2014; [79 FR 37621](https://www.federalregister.gov/citation/79-FR-37621), July 2, 2014; [79 FR 44278](https://www.federalregister.gov/citation/79-FR-44278), July 31, 2014; [79 FR 53136](https://www.federalregister.gov/citation/79-FR-53136), Sept. 8, 2014; [80 FR 61298](https://www.federalregister.gov/citation/80-FR-61298), Oct. 13, 2015; [81 FR 48703](https://www.federalregister.gov/citation/81-FR-48703), July 26, 2016; [81 FR 95013](https://www.federalregister.gov/citation/81-FR-95013), Dec. 27, 2016; [85 FR 18122](https://www.federalregister.gov/citation/85-FR-18122), Apr. 1, 2020; [85 FR 45311](https://www.federalregister.gov/citation/85-FR-45311), July 28, 2020; [86 FR 58013](https://www.federalregister.gov/citation/86-FR-58013), Oct. 20, 2021; [87 FR 17947](https://www.federalregister.gov/citation/87-FR-17947), Mar. 29, 2022; [89 FR 42361](https://www.federalregister.gov/citation/89-FR-42361), May 15, 2024]