(a) Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.
(b) Approvals. See Nos. 000986 and 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 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.''
(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-- ----------------------------------------------------------------------------------------------------------------
Combination in grams/
(i) 4.5 to 9.0................... .................... For increased rate of Feed continuously 000986,
weight gain, improved as sole ration. 054771
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.(ii) 4.5 to 9.0.................. Tylosin............. Finishing swine: As in Feed 100 grams per 000986,
40 or 100........... paragraph (e)(1)(i) of tons (g/ton) 016592,
this section; and for continuously as 054771
control of swine sole ration for at
dysentery associated least 3 weeks
with Brachyspira followed by 40 g/
hyodysenteriae and ton until market
porcine proliferative weight.
enteropathies (PPE, Ractopamine as
ileitis) associated provided by No.
with Lawsonia 000986 with
intracellularis.. tylosin as
provided by Nos.
000986 or 016592
in Sec.
510.600(c) of this
chapter; or
ractopamine as
provided by No.
054771 with
tylosin as
provided by No.
000986 in Sec.
510.600(c) of this
chapter..(iii) 4.5 to 9.0................. Tylosin............. Finishing swine: As in Feed continuously 000986,
100................. paragraph (e)(1)(i) of as sole ration for 016592,
this section; and for 21 days. 054771
control of porcine Ractopamine as
proliferative provided by No.
enteropathies (PPE, 000986 with
ileitis) associated tylosin as
with L. provided by Nos.
intracellularis.. 000986 or 016592
in Sec.
510.600(c) of this
chapter; or
ractopamine as
provided by No.
054771 with
tylosin as
provided by No.
000986 in Sec.
510.600(c) of this
chapter..(iv) 4.5 to 9.0.................. Tylosin............. Finishing swine: As in Feed continuously 000986,
40 to 100........... paragraph (e)(1)(i) of as sole ration for 016592,
this section; for 2 to 6 weeks, 054771
treatment and control immediately after
of swine dysentery treatment with
associated with B. tylosin tartrate
hyodysenteriae and for in drinking water
control of porcine as in Sec.
proliferative 520.2640(d)(3) of
enteropathies (PPE, this chapter.
ileitis) associated Ractopamine as
with L. provided by No.
intracellularis.. 000986 with
tylosin as
provided by Nos.
000986 or 016592
in Sec.
510.600(c) of this
chapter; or
ractopamine as
provided by No.
054771 with
tylosin as
provided by No.
000986 in Sec.
510.600(c) of this
chapter..----------------------------------------------------------------------------------------------------------------
(2) Cattle-- ----------------------------------------------------------------------------------------------------------------
Combination in grams/
(i) 8.2 to 24.6.................. .................... Cattle fed in Feed continuously 000986,
confinement for as sole ration 054771
slaughter: For during the last 28
increased rate of to 42 days on
weight gain and feed..
improved feed
efficiency during the
last 28 to 42 days on
feed.(ii) 8.2 to 24.6................. Monensin 10 to 40 to Cattle fed in As in paragraph 000986,
provide 0.14 to confinement for (e)(2)(i) of this 054771
0.42 mg monensin/lb slaughter: As in section; see
of body weight, paragraph (e)(2)(i) of paragraph Sec.
depending on this section; for 558.355(d) of this
severity of prevention and control chapter.
coccidiosis of coccidiosis due to Ractopamine as
challenge, up to Eimeria bovis and E provided by Nos.
480 mg/head/day. zuernii. 000986 or 054771
in Sec.
510.600(c) of this
chapter; monensin
as provided by No.
000986 in Sec.
510.600(c) of this
chapter.(iii) [Reserved].................(iv) 8.2 to 24.6................. Monensin 10 to 40 to Cattle fed in As in paragraph 000986,
provide 0.14 to confinement for (e)(2)(i) of this 016592,
0.42 mg monensin/lb slaughter: As in section; see Sec. 054771
of body weight, paragraph (e)(2)(i) of Sec. 558.355(d)
depending on this section; for and 558.625(c) of
severity of prevention and control this chapter.
coccidiosis of coccidiosis due to Ractopamine as
challenge, up to Eimeria bovis and E provided by No.
480 mg/head/day, zuernii; and for 000986 with
plus tylosin 8 to reduction of incidence tylosin as
10. of liver abscesses provided by Nos.
caused by 000986 or 016592
Fusobacterium in Sec.
necrophorum and 510.600(c) of this
Arcanobacterium chapter; or
(Actinomyces) pyogenes. ractopamine as
provided by No.
054771 with
tylosin as
provided by No.
000986 in Sec.
510.600(c) of this
chapter.(v) [Reserved]...................(vi) 9.8 to 24.6................. .................... Cattle fed in Feed continuously 000986,
confinement for as sole ration 054771
slaughter: For during the last 28
increased rate of to 42 days on
weight gain, improved feed. Not for
feed efficiency, and animals intended
increased carcass for breeding.
leanness during the
last 28 to 42 days on
feed.(vii) 9.8 to 24.6................ Monensin 10 to 40 to Cattle fed in As in paragraph 000986,
provide 0.14 to confinement for (e)(2)(vi) of this 054771
0.42 mg monensin/lb slaughter: As in section; see
of body weight, paragraph (e)(2)(vi) paragraph Sec.
depending on of this section; for 558.355(d) of this
severity of prevention and control chapter.
coccidiosis of coccidiosis due to Ractopamine as
challenge, up to Eimeria bovis and E provided by Nos.
480 mg/head/day. zuernii. 000986 or 054771
in Sec.
510.600(c) of this
chapter; monensin
as provided by No.
000986 in Sec.
510.600(c) of this
chapter.(viii) 9.8 to 24.6............... Monensin 10 to 40 to Heifers fed in As in paragraph 000986,
provide 0.14 to confinement for (e)(2)(vi) of this 054771
0.42 mg monensin/lb slaughter: As in section; see Sec.
of body weight, paragraph (e)(2)(vi) Sec. 558.342(d)
depending on of this section; for and 558.355(d) of
severity of prevention and control this chapter.
coccidiosis of coccidiosis due to Melengestrol
challenge, up to Eimeria bovis and E. acetate as
480 mg/head/day, zuernii; and for provided by Nos.
plus melengestrol suppression of estrus 000986 and 054771
acetate to provide (heat).. or 021641 in Sec.
0.25 to 0.5 mg/head/ 510.600(c) of
day. this chapter..(ix) 9.8 to 24.6................. Monensin 10 to 40 to Cattle fed in As in paragraph 000986,
provide 0.14 to confinement for (e)(2)(vi) of this 016592,
0.42 mg monensin/lb slaughter: As in section; see Sec. 054771
of body weight, paragraph (e)(2)(vi) Sec. 558.355(d)
depending on of this section; for and 558.625(c) of
severity of prevention and control this chapter.
coccidiosis of coccidiosis due to Ractopamine and
challenge, up to Eimeria bovis and E monensin as
480 mg/head/day, zuernii; and for provided by No.
plus tylosin 8 to reduction of incidence 000986 with
10. of liver abscesses tylosin as
caused by provided by Nos.
Fusobacterium 000986 or 016592
necrophorum and in Sec.
Arcanobacterium 510.600(c) of this
(Actinomyces) pyogenes. chapter; or
ractopamine as
provided by No.
054771 with
monensin and
tylosin as
provided by No.
000986 in Sec.
510.600(c) of this
chapter.
(x) 9.8 to 24.6.................. Monensin 10 to 40 to Heifers fed in As in paragraph 000986,
provide 0.14 to confinement for (e)(2)(vi) of this 016592,
0.42 mg monensin/lb slaughter: As in section; see 054771
of body weight, paragraph (e)(2)(vi) paragraphs Sec.
depending on of this section; for Sec. 558.342(d),
severity of prevention and control 558.355(d) and
coccidiosis of coccidiosis due to 558.625(c) of this
challenge, up to Eimeria bovis and E chapter.
480 mg/head/day, zuernii; for reduction Ractopamine,
plus tylosin 8 to of incidence of liver monensin, and
10, plus abscesses caused by tylosin as
melengestrol Fusobacterium provided by No.
acetate to provide necrophorum and 000986 with
0.25 to 0.5 mg/head/ Arcanobacterium melengestrol
day. (Actinomyces) acetate as
pyogenes; and for provided by Nos.
suppression of estrus 000986 or 054771
(heat). in Sec.
510.600(c) of this
chapter; or
ractopamine and
monensin as
provided by No.
000986 with
tylosin as
provided by Nos.
000986 or 016592
and melengestrol
acetate as
provided by No.
054771 in Sec.
510.600(c) of this
chapter; or
ractopamine as
provided by No.
054771 with
monensin and
tylosin as
provided by No.
000986 and
melengestrol
acetate provided
by No. 054771 in
Sec. 510.600(c)
of this chapter.(xi) Not to exceed 800; to .................... Cattle fed in Top dress in a 000986,
provide 70 to 400 mg/head/day.. confinement for minimum of 1.0 lb 054771
slaughter: As in of medicated feed..
paragraph (e)(2)(i) of
this section..(xii) Not to exceed 800; to Monensin 10 to 40 to Cattle fed in Top dress 000986,
provide 70 to 400 mg/head/day. provide 0.14 to confinement for ractopamine in a 054771
0.42 mg monensin/lb slaughter: As in minimum of 1.0 lb
of body weight, paragraph (e)(2)(i) of of medicated feed
depending on this section; for during the last 28
severity of prevention and control to 42 days on
coccidiosis of coccidiosis due to feed. Not for
challenge, up to Eimeria bovis and E animals intended
480 mg/head/day. zuernii. for breeding. See
Sec. 558.355(d).
Ractopamine as
provided by Nos.
000986 or 054771
in Sec.
510.600(c) of this
chapter; monensin
as provided by No.
000986 in Sec.
510.600(c) of this
chapter.(xiii) Not to exceed 800; to Monensin 10 to 40 to Cattle fed in Top dress 000986,
provide 70 to 400 mg/head/day. provide 0.14 to confinement for ractopamine in a 016592,
0.42 mg monensin/lb slaughter: As in minimum of 1.0 lb 054771
of body weight, paragraph (e)(2)(i) of of medicated feed
depending on this section; for during the last 28
severity of prevention and control to 42 days on
coccidiosis of coccidiosis due to feed. Not for
challenge, up to Eimeria bovis and E animals intended
480 mg/head/day, zuernii; and for for breeding. See
plus tylosin 8 to reduction of incidence Sec. Sec.
10. of liver abscesses 558.355(d) and
caused by 558.625(c).
Fusobacterium Ractopamine and
necrophorum and monensin as
Arcanobacterium provided by No.
(Actinomyces) pyogenes. 000986 with
tylosin as
provided by Nos.
000986 or 016592
in Sec.
510.600(c) of this
chapter; or
ractopamine as
provided by No.
054771 with
monensin and
tylosin as
provided by No.
000986 in Sec.
510.600(c) of this
chapter.----------------------------------------------------------------------------------------------------------------
(3) Turkeys-- ----------------------------------------------------------------------------------------------------------------
Combination in grams/
(i) 4.6 to 11.8 (5 to 13 ppm).... .................... Finishing hen turkeys: Feed continuously 000986
For increased rate of as sole ration
weight gain and during the last 7
improved feed to 14 days prior
efficiency when fed to slaughter..
for the last 7 to 14
days prior to
slaughter..----------------------------------------------------------------------------------------------------------------
(ii) 4.6 to 11.8 (5 to 13 ppm)... .................... Finishing tom turkeys: Feed continuously 000986
For increased rate of as sole ration
weight gain and during the last 14
improved feed days prior to
efficiency when fed slaughter. Feeding
for the last 14 days ractopamine to tom
prior to slaughter.. turkeys during
periods of
excessive heat can
result in
increased
mortality..(iii) 4.6 to 11.8 (5 to 13 ppm).. Monensin 54 to 90... Finishing hen turkeys: Feed continuously 000986
As in paragraph as sole ration
(e)(3)(i) of this during the last 7
(3)(i) of this during the last 7
(i) of this during the last 7
section; and for the to 14 days prior
prevention of to slaughter. See
coccidiosis in growing Sec. 558.355(d)..
turkeys caused by
Eimeria adenoeides, E.
meleagrimitis and E.
gallopavonis..(iv) 4.6 to 11.8 (5 to 13 ppm)... Monensin 54 to 90... Finishing tom turkeys: Feed continuously 000986
As in paragraph as sole ration
(e)(3)(ii) of this during the last 14
(3)(ii) of this during the last 14
(ii) of this during the last 14
section; and for the days prior to
prevention of slaughter. Feeding
coccidiosis in growing ractopamine to tom
turkeys caused by turkeys during
Eimeria adenoeides, E. periods of
meleagrimitis and E. excessive heat can
gallopavonis.. result in
increased
mortality. See
Sec. 558.355(d)..---------------------------------------------------------------------------------------------------------------- [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]