§558.500. Ractopamine.
21 C.F.R. § 558.500
Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.
Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride.
Nos. 051311 and 066104: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride.
Related tolerances. See § 556.570 of this chapter.
Special considerations.
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.”
Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for swine shall bear the following:
“No increased benefit has been shown when ractopamine hydrochloride concentrations in the diet are greater than 4.5 g/ton (5 ppm).”
“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.”
“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.”
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.”
Tylosin in combinations as tylosin phosphate.
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.
Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for cattle feeds shall bear the following:
“Behavioral signs such as agitation and decreased feed consumption have been reported in cattle fed ractopamine hydrochloride.”
“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.”
Conditions of use—
Swine—
Cattle.
Turkeys—
Ractopamine may also be used in combination with tylosin in as in § 558.625.
Notes, amendments, and revision history
Amendments
[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; 91 FR 33072, June 3, 2026]
Authority
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Source
Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 91 FR 33072, June 3, 2026]